Carboplatin And Paclitaxel With Or Without CP-751, 871 (An IGF-1R Inhibitor) For Advanced NSCLC Of Squamous, Large Cell And Adenosquamous Carcinoma Histology

• Sponsor: Pfizer (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00596830
• Collaborator: (none)
• Enrollment: 681
• Locations: 280
• Arms: 2
• Duration (Months): 53
• Patients Per Site: 2.4
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

Determine whether the addition of CP- 751,871 in combination with paclitaxel plus carboplatin prolongs survival in patients with locally advanced (Stage IIIB with pleural effusion) or metastatic (Stage IV or recurrent) NSCLC of non adenocarcinoma histology.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Squamous Cell; Carcinoma, Adenosquamous; Carcinoma, Large Cell; Carcinoma, Non-Small-Cell Lung	Drug: CP-751,871 (Figitumumab); Drug: Carboplatin; Drug: Paclitaxel; Drug: Carboplatin; Drug: Paclitaxel	Phase 3

Detailed Description

The study was discontinued on December 29, 2009 due to an analysis by an independent Data Safety Monitoring Committee indicating that the addition of CP-751,871 [figitumumab] to paclitaxel plus carboplatin would be unlikely to meet the primary endpoint of improving overall survival compared to paclitaxel plus carboplatin alone. The DSMC recommendation to terminate the trial was based on futility, not on specific safety concerns; however, the DSMC recommended to investigate hyperglycemia as a potential contributor to the morbidity of the patients.

Study Design

• Study Type: Interventional
• Actual Enrollment: 681 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized, Open Label, Phase III Trial Of CP- 751,871 In Combination With Paclitaxel And Carboplatin Versus Paclitaxel And Carboplatin In Patients With Non Small Cell Lung Cancer
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A Patients in Arm A will receive CP-751, 871 in combination with paclitaxel and carboplatin intravenously every 21 days for up to six cycles.'	Drug: CP-751,871 (Figitumumab); CP 751,871 is a potent and selective fully human monoclonal antibody against the insulin like growth factor 1 receptor (IGF-1R). Patients in Arm A will receive CP-751, 871 intravenously every 21 days for up to six cycles.; Drug: Carboplatin; Carboplatin is a standard chemotherapeutic agent used in patients with lung cancer. Patients in Arm A will receive carboplatin intravenously every 21 days for up to six cycles.; Drug: Paclitaxel; Paclitaxel is a standard chemotherapeutic agent used in patients with lung cancer. Patients in Arm A will receive paclitaxel intravenously every 21 days for up to six cycles.
Active Comparator: B Patient in Arm B will receive paclitaxel and carboplatin intravenously every 21 days for up to six cycles.	Drug: Carboplatin; Carboplatin is a standard chemotherapeutic agent used in patients with lung cancer. Patient in Arm B will receive carboplatin intravenously every 21 days for up to six cycles.; Drug: Paclitaxel; Paclitaxel is a standard chemotherapeutic agent used in patients with lung cancer. Patient in Arm B will receive paclitaxel intravenously every 21 days for up to six cycles.

Outcome Measures

Primary Outcome Measures

1. Overall Survival (OS) [Baseline until death, assessed monthly after end of treatment, up to 30 months]

   Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.

Secondary Outcome Measures

1. Progression-Free Survival (PFS) [At baseline, every 6 weeks until radiological disease progression or the participant begins a subsequent anticancer therapy, up to 22.7 months.]

   PFS was defined as the time from randomization to first progression or death due to any cause, whichever came first. Participants last known to be alive and progression-free, with baseline and >=1 on-study assessment, were censored at last disease assessment verifying lack of progression. Progression was determined by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 (20% increase in the sum of target lesions' longest diameter over nadir, unequivocal progression of non-target disease, or appearance of new lesions).

2. Percentage of Participants With Objective Response (OR) [At baseline, every 6 weeks until radiological disease progression has been documented or the participant begins a subsequent anticancer therapy, up to 22.7 months]

   Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response(PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as complete disappearance of all target lesions and non-target disease. No new lesons. PR defined as ≥30% decrease under baseline of the sum of diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions.

3. European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) [Day 1 of every cycle (3-week cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months]

   EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.

4. European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13) Score [Day 1 of every cycle (3-week cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months]

   QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.

5. Euro Quality of Life (EQ-5D)- Health State Profile Utility Score [Day 1 of every cycle (3-weeks cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months]

   EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range of -0.594 to 1; higher score indicates a better health state.

6. Maximum Observed Plasma Concentration (Cmax) for Figitumumab [Cycle 1, Day 1 (predose and 1 hour after end of infusion); Day 1 of Cycles 2, 4, 6 (predose); Cycle 5 Day 1 (predose, 1 hour after end of infusion); 28 days and 150 days after the last figi dose]

7. Minimum Observed Plasma Trough Concentration (Cmin)for Figitumumab [Cycle 1, Day 1 (predose and 1 hour after end of infusion); Day 1 of Cycles 2, 4, 6 (predose); Cycle 5 Day 1 (predose, 1 hour after end of infusion); 28 days and 150 days after the last figi dose]

8. Number of Participants With Total Anti-drug Antibodies (ADA) [Cycles 1, 2, and 4 (predose); 28 days and 150 days after the last figi dose]

   ADAs are immunogenicity indicators to figitumumab. Participants reporting positive for ADAs are indicated by an endpoint titer of no less than 6.64.

9. Change From Baseline in Serum Insulin Growth Factor 1 (IGF1) Levels [Cycles 1 and 4 (predose) and at end of treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Confirmed diagnosis of non small cell lung cancer with a primary histology of predominantly squamous cell, large cell or adenosquamous carcinoma.

• Advanced NSCLC with documented Stage IIIB (with pleural effusion) or Stage IV or recurrent disease.

• No prior systemic treatment for NSCLC, except for adjuvant chemotherapy. Adjuvant chemotherapy must have completed for greater than or equal to 12 months prior to randomization.

• Prior surgery or radiation therapy is permitted if completed at least 3 weeks prior to randomization and all acute toxicities have resolved.

• ECOG performance status (PS) 0 or 1.

Exclusion Criteria:

• Patients with symptomatic central nervous system (CNS) metastases are not permitted.

• Patients requiring chronic steroid use or patients with uncontrolled diabetes are not permitted.

• Patients with other active cancer types are not permitted.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Florence	Alabama	United States	35630
2	Pfizer Investigational Site	Huntsville	Alabama	United States	35805
3	Pfizer Investigational Site	Muscle Shoals	Alabama	United States	35661
4	Pfizer Investigational Site	Phoenix	Arizona	United States	85012
5	Pfizer Investigational Site	Scottsdale	Arizona	United States	85258
6	Pfizer Investigational Site	Hot Springs	Arkansas	United States	71913
7	Pfizer Investigational Site	Aurora	Colorado	United States	80012
8	Pfizer Investigational Site	Boulder	Colorado	United States	80303
9	Pfizer Investigational Site	Colorado Springs	Colorado	United States	80907
10	Pfizer Investigational Site	Colorado Springs	Colorado	United States	80909
11	Pfizer Investigational Site	Denver	Colorado	United States	80218
12	Pfizer Investigational Site	Denver	Colorado	United States	80220
13	Pfizer Investigational Site	Lakewood	Colorado	United States	80228
14	Pfizer Investigational Site	Littleton	Colorado	United States	80120
15	Pfizer Investigational Site	Lone Tree	Colorado	United States	80124
16	Pfizer Investigational Site	Longmont	Colorado	United States	80501
17	Pfizer Investigational Site	Parker	Colorado	United States	80138
18	Pfizer Investigational Site	Thornton	Colorado	United States	80260
19	Pfizer Investigational Site	Norwalk	Connecticut	United States	06856
20	Pfizer Investigational Site	Norwich	Connecticut	United States	06360
21	Pfizer Investigational Site	Hudson	Florida	United States	34667
22	Pfizer Investigational Site	Jacksonville	Florida	United States	32207
23	Pfizer Investigational Site	Lake City	Florida	United States	32024
24	Pfizer Investigational Site	Lake City	Florida	United States	32055
25	Pfizer Investigational Site	Miramar Beach	Florida	United States	32550
26	Pfizer Investigational Site	New Port Richey	Florida	United States	34655
27	Pfizer Investigational Site	Orlando	Florida	United States	32803
28	Pfizer Investigational Site	Orlando	Florida	United States	32804
29	Pfizer Investigational Site	Pensacola	Florida	United States	32504
30	Pfizer Investigational Site	Pensacola	Florida	United States	32514
31	Pfizer Investigational Site	Port St. Lucie	Florida	United States	34952
32	Pfizer Investigational Site	Spring Hill	Florida	United States	34608
33	Pfizer Investigational Site	Alpharetta	Georgia	United States	30005
34	Pfizer Investigational Site	Atlanta	Georgia	United States	30318
35	Pfizer Investigational Site	Atlanta	Georgia	United States	30341
36	Pfizer Investigational Site	Atlanta	Georgia	United States	30342
37	Pfizer Investigational Site	Conyers	Georgia	United States	30094
38	Pfizer Investigational Site	Cumming	Georgia	United States	30041
39	Pfizer Investigational Site	Decatur	Georgia	United States	30033
40	Pfizer Investigational Site	Duluth	Georgia	United States	30096
41	Pfizer Investigational Site	Lake Spivey	Georgia	United States	30236
42	Pfizer Investigational Site	Lawrenceville	Georgia	United States	30046
43	Pfizer Investigational Site	Macon	Georgia	United States	31217
44	Pfizer Investigational Site	Marietta	Georgia	United States	30060
45	Pfizer Investigational Site	Snellville	Georgia	United States	30078
46	Pfizer Investigational Site	Coeur d' Alene	Idaho	United States	83814
47	Pfizer Investigational Site	Arlington Heights	Illinois	United States	60005
48	Pfizer Investigational Site	Aurora	Illinois	United States	60504
49	Pfizer Investigational Site	Chicago	Illinois	United States	60637
50	Pfizer Investigational Site	Elk Grove Village	Illinois	United States	60007
51	Pfizer Investigational Site	Galesburg	Illinois	United States	61401
52	Pfizer Investigational Site	Winfield	Illinois	United States	60190
53	Pfizer Investigational Site	Yorkville	Illinois	United States	60560
54	Pfizer Investigational Site	Avon	Indiana	United States	46123
55	Pfizer Investigational Site	Beech Grove	Indiana	United States	46107
56	Pfizer Investigational Site	Hobart	Indiana	United States	46342
57	Pfizer Investigational Site	Hobart	Indiana	United States	46432
58	Pfizer Investigational Site	Indianapolis	Indiana	United States	46237
59	Pfizer Investigational Site	Indianapolis	Indiana	United States	46260
60	Pfizer Investigational Site	Mooresville	Indiana	United States	46158-1737
61	Pfizer Investigational Site	Mooresville	Indiana	United States	46158
62	Pfizer Investigational Site	Munster	Indiana	United States	46321
63	Pfizer Investigational Site	Cedar Rapids	Iowa	United States	52402
64	Pfizer Investigational Site	Kansas City	Kansas	United States	66112
65	Pfizer Investigational Site	Overland Park	Kansas	United States	66210
66	Pfizer Investigational Site	Shawnee Mission	Kansas	United States	66204
67	Pfizer Investigational Site	Louisville	Kentucky	United States	40202
68	Pfizer Investigational Site	Louisville	Kentucky	United States	40207
69	Pfizer Investigational Site	Baltimore	Maryland	United States	21225
70	Pfizer Investigational Site	Baltimore	Maryland	United States	21237
71	Pfizer Investigational Site	Lawrence	Massachusetts	United States	01842
72	Pfizer Investigational Site	Quincy	Massachusetts	United States	02169
73	Pfizer Investigational Site	Stoneham	Massachusetts	United States	02180
74	Pfizer Investigational Site	Weymouth	Massachusetts	United States	02189
75	Pfizer Investigational Site	Worcester	Massachusetts	United States	01605
76	Pfizer Investigational Site	Detroit	Michigan	United States	48201
77	Pfizer Investigational Site	Farmington Hills	Michigan	United States	48334
78	Pfizer Investigational Site	St. Joseph	Michigan	United States	49085
79	Pfizer Investigational Site	St. Louis Park	Minnesota	United States	55426
80	Pfizer Investigational Site	Columbus	Mississippi	United States	39705
81	Pfizer Investigational Site	Corinth	Mississippi	United States	38834
82	Pfizer Investigational Site	Oxford	Mississippi	United States	38655
83	Pfizer Investigational Site	Southaven	Mississippi	United States	38671
84	Pfizer Investigational Site	Tupelo	Mississippi	United States	38801
85	Pfizer Investigational Site	Kansas City	Missouri	United States	64131
86	Pfizer Investigational Site	Kansas City	Missouri	United States	64154
87	Pfizer Investigational Site	Lee's Summit	Missouri	United States	64064
88	Pfizer Investigational Site	Lincoln	Nebraska	United States	68506
89	Pfizer Investigational Site	Lincoln	Nebraska	United States	68510
90	Pfizer Investigational Site	Lincoln	Nebraska	United States	68516
91	Pfizer Investigational Site	Las Vegas	Nevada	United States	89102
92	Pfizer Investigational Site	Las Vegas	Nevada	United States	89106
93	Pfizer Investigational Site	Lebanon	New Hampshire	United States	03756-0001
94	Pfizer Investigational Site	Manchester	New Hampshire	United States	03102
95	Pfizer Investigational Site	Lake Success	New York	United States	11042
96	Pfizer Investigational Site	Manhasset	New York	United States	11030
97	Pfizer Investigational Site	New Hyde Park	New York	United States	11040
98	Pfizer Investigational Site	Oneida	New York	United States	13421
99	Pfizer Investigational Site	Oswego	New York	United States	13126
100	Pfizer Investigational Site	Syracuse	New York	United States	13210-2306
101	Pfizer Investigational Site	Syracuse	New York	United States	13210
102	Pfizer Investigational Site	Burlington	North Carolina	United States	27215
103	Pfizer Investigational Site	Canton	Ohio	United States	44718
104	Pfizer Investigational Site	Cleveland	Ohio	United States	44195
105	Pfizer Investigational Site	Dover	Ohio	United States	44622
106	Pfizer Investigational Site	Tulsa	Oklahoma	United States	74104
107	Pfizer Investigational Site	Tulsa	Oklahoma	United States	74133
108	Pfizer Investigational Site	Tulsa	Oklahoma	United States	74136
109	Pfizer Investigational Site	Clairton	Pennsylvania	United States	15025
110	Pfizer Investigational Site	Greensburg	Pennsylvania	United States	15601
111	Pfizer Investigational Site	Johnstown	Pennsylvania	United States	15901
112	Pfizer Investigational Site	McKeesport	Pennsylvania	United States	15132
113	Pfizer Investigational Site	Philadelphia	Pennsylvania	United States	19104
114	Pfizer Investigational Site	Philadelphia	Pennsylvania	United States	19106
115	Pfizer Investigational Site	Pittsburgh	Pennsylvania	United States	15215
116	Pfizer Investigational Site	Pittsburgh	Pennsylvania	United States	15232
117	Pfizer Investigational Site	Pittsburgh	Pennsylvania	United States	15237
118	Pfizer Investigational Site	Radnor	Pennsylvania	United States	19087
119	Pfizer Investigational Site	Sayre	Pennsylvania	United States	18840
120	Pfizer Investigational Site	Wexford	Pennsylvania	United States	15090
121	Pfizer Investigational Site	Columbia	South Carolina	United States	29203
122	Pfizer Investigational Site	Sumter	South Carolina	United States	29150
123	Pfizer Investigational Site	Bartlett	Tennessee	United States	38133
124	Pfizer Investigational Site	Knoxville	Tennessee	United States	37909
125	Pfizer Investigational Site	Knoxville	Tennessee	United States	37916
126	Pfizer Investigational Site	Knoxville	Tennessee	United States	37932
127	Pfizer Investigational Site	Maryville	Tennessee	United States	37804
128	Pfizer Investigational Site	Memphis	Tennessee	United States	38119
129	Pfizer Investigational Site	Memphis	Tennessee	United States	38120
130	Pfizer Investigational Site	Austin	Texas	United States	78705
131	Pfizer Investigational Site	Austin	Texas	United States	78731
132	Pfizer Investigational Site	Austin	Texas	United States	78745
133	Pfizer Investigational Site	Austin	Texas	United States	78758
134	Pfizer Investigational Site	Dallas	Texas	United States	75230-2510
135	Pfizer Investigational Site	Fort Sam Houston	Texas	United States	78234
136	Pfizer Investigational Site	Fort Worth	Texas	United States	76111
137	Pfizer Investigational Site	Fort Worth	Texas	United States	76177
138	Pfizer Investigational Site	Grapevine	Texas	United States	76051
139	Pfizer Investigational Site	Houston	Texas	United States	77030
140	Pfizer Investigational Site	Irving	Texas	United States	75063
141	Pfizer Investigational Site	Longview	Texas	United States	75601
142	Pfizer Investigational Site	Plano	Texas	United States	75075-7787
143	Pfizer Investigational Site	Round Rock	Texas	United States	78665
144	Pfizer Investigational Site	Round Rock	Texas	United States	78681
145	Pfizer Investigational Site	San Antonio	Texas	United States	78229
146	Pfizer Investigational Site	San Marcos	Texas	United States	78666
147	Pfizer Investigational Site	Tyler	Texas	United States	75702
148	Pfizer Investigational Site	Bountiful	Utah	United States	84010
149	Pfizer Investigational Site	Layton	Utah	United States	84041
150	Pfizer Investigational Site	Murray	Utah	United States	84157
151	Pfizer Investigational Site	Provo	Utah	United States	84604
152	Pfizer Investigational Site	Salt Lake City	Utah	United States	84102
153	Pfizer Investigational Site	Salt Lake City	Utah	United States	84106
154	Pfizer Investigational Site	West Valley City	Utah	United States	84120
155	Pfizer Investigational Site	Arlington	Virginia	United States	22205
156	Pfizer Investigational Site	Christiansburg	Virginia	United States	24073
157	Pfizer Investigational Site	Fairfax	Virginia	United States	22031
158	Pfizer Investigational Site	Gainesville	Virginia	United States	20155
159	Pfizer Investigational Site	Leesburg	Virginia	United States	20176
160	Pfizer Investigational Site	Roanoke	Virginia	United States	24014
161	Pfizer Investigational Site	Salem	Virginia	United States	24153
162	Pfizer Investigational Site	Winchester	Virginia	United States	22601
163	Pfizer Investigational Site	Woodbridge	Virginia	United States	22191
164	Pfizer Investigational Site	Wytheville	Virginia	United States	24382
165	Pfizer Investigational Site	Seattle	Washington	United States	98104
166	Pfizer Investigational Site	Seattle	Washington	United States	98122
167	Pfizer Investigational Site	Spokane Valley	Washington	United States	99202
168	Pfizer Investigational Site	Spokane	Washington	United States	99216
169	Pfizer Investigational Site	Spokane	Washington	United States	99218
170	Pfizer Investigational Site	Albury	New South Wales	Australia	2640
171	Pfizer Investigational Site	Port Macquarie	New South Wales	Australia	2444
172	Pfizer Investigational Site	Geelong	Victoria	Australia	3220
173	Pfizer Investigational Site	Wodonga	Victoria	Australia	3690
174	Pfizer Investigational Site	Linz		Austria	A-4010
175	Pfizer Investigational Site	Wien		Austria	A-1090
176	Pfizer Investigational Site	Rio de Janeiro	RJ	Brazil	20230-130
177	Pfizer Investigational Site	Rio de Janeiro	RJ	Brazil	20231 -050
178	Pfizer Investigational Site	Higienopolis	Sao Paulo/ Brazil	Brazil	01224-010
179	Pfizer Investigational Site	Sao Paulo	SP	Brazil	01219-000
180	Pfizer Investigational Site	Sao Paulo	SP	Brazil	01221-020
181	Pfizer Investigational Site	Sao Paulo	SP	Brazil	01224-010
182	Pfizer Investigational Site	Sofia		Bulgaria	1233
183	Pfizer Investigational Site	Sofia		Bulgaria	1527
184	Pfizer Investigational Site	Sofia		Bulgaria	1756
185	Pfizer Investigational Site	Varna		Bulgaria	9000
186	Pfizer Investigational Site	Edmonton	Alberta	Canada	T6G 1Z2
187	Pfizer Investigational Site	Levis	Quebec	Canada	G6V 3Z1
188	Pfizer Investigational Site	Nova Ves pod Plesi		Czech Republic	262 04
189	Pfizer Investigational Site	Praha 8		Czech Republic	180 81
190	Pfizer Investigational Site	Pribram I		Czech Republic	261 26
191	Pfizer Investigational Site	Pribram V		Czech Republic	261 95
192	Pfizer Investigational Site	Helsinki		Finland	00290
193	Pfizer Investigational Site	Pori		Finland	28500
194	Pfizer Investigational Site	Caen Cedex 05		France	14076
195	Pfizer Investigational Site	Caen Cedex		France	14033
196	Pfizer Investigational Site	Clermond-Ferrand Cedex 01		France	63003
197	Pfizer Investigational Site	Dijon		France	21079
198	Pfizer Investigational Site	Lyon Cedex 04		France	69317
199	Pfizer Investigational Site	Nantes Cedex 2		France	44202
200	Pfizer Investigational Site	Rennes Cedex 9		France	35033
201	Pfizer Investigational Site	Saint Herblain Cedex		France	44805
202	Pfizer Investigational Site	Saint Pierre la Réunion Cedex		France	97448
203	Pfizer Investigational Site	Grosshansdorf		Germany	22927
204	Pfizer Investigational Site	Karlsruhe		Germany	76137
205	Pfizer Investigational Site	Leipzig		Germany	04207
206	Pfizer Investigational Site	Mainz		Germany	55131
207	Pfizer Investigational Site	Oldenburg		Germany	26121
208	Pfizer Investigational Site	Thessaloniki	Pylaia	Greece	57001
209	Pfizer Investigational Site	Athens		Greece	10676
210	Pfizer Investigational Site	Athens		Greece	11527
211	Pfizer Investigational Site	Thessaloniki		Greece	56429
212	Pfizer Investigational Site	Kowloon		Hong Kong	0
213	Pfizer Investigational Site	Shatin, New Territories		Hong Kong
214	Pfizer Investigational Site	Tuen Mun		Hong Kong
215	Pfizer Investigational Site	Budapest		Hungary	1525
216	Pfizer Investigational Site	Deszk		Hungary	6772
217	Pfizer Investigational Site	Szekesfehervar		Hungary	8000
218	Pfizer Investigational Site	Szombathely		Hungary	9700
219	Pfizer Investigational Site	Torokbalint		Hungary	2045
220	Pfizer Investigational Site	Navrangpura / Ahmedabad	Gujarat	India	380 009
221	Pfizer Investigational Site	Bangalore	Karnataka	India	560 078
222	Pfizer Investigational Site	Mumbai	Maharashtra	India	400 012
223	Pfizer Investigational Site	Nagpur	Maharashtra	India	440012
224	Pfizer Investigational Site	New Delhi		India	110 030
225	Pfizer Investigational Site	Genova		Italy	16132
226	Pfizer Investigational Site	Orbassano (TO)		Italy	10043
227	Pfizer Investigational Site	Padova		Italy	35128
228	Pfizer Investigational Site	Roma		Italy	00152
229	Pfizer Investigational Site	Kashiwa	Chiba	Japan
230	Pfizer Investigational Site	Matsuyama-shi	Ehime	Japan
231	Pfizer Investigational Site	Gifu-shi	Gifu	Japan
232	Pfizer Investigational Site	Sapporo-shi	Hokkaido	Japan
233	Pfizer Investigational Site	Akashi	Hyogo	Japan
234	Pfizer Investigational Site	Yokohama-city	Kanagawa	Japan
235	Pfizer Investigational Site	Sakai-shi	Osaka-fu	Japan
236	Pfizer Investigational Site	Osaka-city	Osaka	Japan
237	Pfizer Investigational Site	Osakasayama-shi	Osaka	Japan
238	Pfizer Investigational Site	Chuo-Ku	Tokyo	Japan
239	Pfizer Investigational Site	Tokyo		Japan
240	Pfizer Investigational Site	Gyeonggi-do		Korea, Republic of	410-769
241	Pfizer Investigational Site	Seoul		Korea, Republic of	110-744
242	Pfizer Investigational Site	Seoul		Korea, Republic of	135-710
243	Pfizer Investigational Site	Seoul		Korea, Republic of	138-736
244	Pfizer Investigational Site	Gdansk		Poland	80-952
245	Pfizer Investigational Site	Krakow		Poland	31-115
246	Pfizer Investigational Site	Siedlce		Poland	08-110
247	Pfizer Investigational Site	Warszawa		Poland	01-138
248	Pfizer Investigational Site	Warszawa		Poland	02-097
249	Pfizer Investigational Site	Warszawa		Poland	02-781
250	Pfizer Investigational Site	Wroclaw		Poland	53-439
251	Pfizer Investigational Site	Ponce		Puerto Rico	00716
252	Pfizer Investigational Site	Moscow		Russian Federation	111033
253	Pfizer Investigational Site	Moscow		Russian Federation	115478
254	Pfizer Investigational Site	Saint-Petersburg		Russian Federation	197089
255	Pfizer Investigational Site	Samara		Russian Federation	443066
256	Pfizer Investigational Site	Sochi		Russian Federation	354057
257	Pfizer Investigational Site	St-Petersburg		Russian Federation	194044
258	Pfizer Investigational Site	St. Petersburg		Russian Federation	198255
259	Pfizer Investigational Site	Nitra-Zobor		Slovakia	949 88
260	Pfizer Investigational Site	Nove Zamky		Slovakia	94034
261	Pfizer Investigational Site	Poprad		Slovakia	058 01
262	Pfizer Investigational Site	L'hospitalet de Llobregat	Barcelona	Spain	08907
263	Pfizer Investigational Site	Santander	Cantabria	Spain	39008
264	Pfizer Investigational Site	Pamplona	Navarra	Spain	31008
265	Pfizer Investigational Site	Cordoba		Spain	14004
266	Pfizer Investigational Site	Madrid		Spain	28033
267	Pfizer Investigational Site	Valencia		Spain	46010
268	Pfizer Investigational Site	Fribourg		Switzerland	1708
269	Pfizer Investigational Site	Zuerich		Switzerland	8091
270	Pfizer Investigational Site	Niao Sung Hsiang	Kaohsiung Hsien	Taiwan	833
271	Pfizer Investigational Site	Tainan		Taiwan	704
272	Pfizer Investigational Site	Taipei		Taiwan	100
273	Pfizer Investigational Site	Taipei		Taiwan	112
274	Pfizer Investigational Site	Adana		Turkey	01330
275	Pfizer Investigational Site	Ankara		Turkey	06100
276	Pfizer Investigational Site	Dnipropetrovsk		Ukraine	49102
277	Pfizer Investigational Site	Donetsk		Ukraine	83092
278	Pfizer Investigational Site	Kyiv		Ukraine	03115
279	Pfizer Investigational Site	Lviv		Ukraine	79031
280	Pfizer Investigational Site	Sumy		Ukraine	40005

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00596830
• Other Study ID Numbers: A4021016
• First Posted: Jan 17, 2008
• Last Update Posted: Jan 13, 2014
• Last Verified: Dec 1, 2013

• Keywords provided by Pfizer: IGF-1R inhibitor; Non-small-cell lung carcinoma; CP-751; 871
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Non-Small-Cell Lung; Carcinoma, Squamous Cell; Carcinoma, Large Cell; Carcinoma, Adenosquamous; Paclitaxel; Albumin-Bound Paclitaxel; Carboplatin

Study Results

Participant Flow

Arm/Group Title	Figitumumab + Paclitaxel and Carboplatin	Paclitaxel and Carboplatin (Chemo)
Arm/Group Description	Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.	Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
Period Title: Overall Study
STARTED	342	339
Treated	339	332
COMPLETED	0	0
NOT COMPLETED	342	339

Baseline Characteristics

Arm/Group Title	Figitumumab + Paclitaxel and Carboplatin	Paclitaxel and Carboplatin (Chemo)	Total
Arm/Group Description	Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.	Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.	Total of all reporting groups
Overall Participants	342	339	681
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.8 (9.0)	61.8 (9.1)	61.8 (9.0)
Sex: Female, Male (Count of Participants)
Female	81 23.7%	79 23.3%	160 23.5%
Male	261 76.3%	260 76.7%	521 76.5%

Outcome Measures

1. Primary Outcome

Title	Overall Survival (OS)
Description	Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.
Time Frame	Baseline until death, assessed monthly after end of treatment, up to 30 months

Outcome Measure Data

Analysis Population Description

All randomized participants where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.

Arm/Group Title	Figitumumab + Paclitaxel and Carboplatin	Paclitaxel and Carboplatin (Chemo)
Arm/Group Description	Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.	Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
Measure Participants	342	339
Median (95% Confidence Interval) [months]	8.6	9.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Figitumumab + Paclitaxel and Carboplatin, Paclitaxel and Carboplatin (Chemo)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.064
	Comments	The p-value stated is the 2-sided p-value from the log rank test stratified by gender, prior adjuvant chemotherapy, and histology.
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.179
	Confidence Interval	(2-Sided) 95%; 0.990 to 1.404
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Progression-Free Survival (PFS)
Description	PFS was defined as the time from randomization to first progression or death due to any cause, whichever came first. Participants last known to be alive and progression-free, with baseline and >=1 on-study assessment, were censored at last disease assessment verifying lack of progression. Progression was determined by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 (20% increase in the sum of target lesions' longest diameter over nadir, unequivocal progression of non-target disease, or appearance of new lesions).
Time Frame	At baseline, every 6 weeks until radiological disease progression or the participant begins a subsequent anticancer therapy, up to 22.7 months.

Outcome Measure Data

Analysis Population Description

All randomized participants where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.

Arm/Group Title	Figitumumab + Paclitaxel and Carboplatin	Paclitaxel and Carboplatin (Chemo)
Arm/Group Description	Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.	Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
Measure Participants	342	339
Median (95% Confidence Interval) [months]	4.7	4.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Figitumumab + Paclitaxel and Carboplatin, Paclitaxel and Carboplatin (Chemo)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.270
	Comments	2-sided p-value is from the unstratified log-rank test
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.103
	Confidence Interval	(2-Sided) 95%; 0.925 to 1.315
	Parameter Dispersion	Type: Value:
	Estimation Comments	HR was based on the Cox proportional hazards model

3. Secondary Outcome

Title	Percentage of Participants With Objective Response (OR)
Description	Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response(PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as complete disappearance of all target lesions and non-target disease. No new lesons. PR defined as ≥30% decrease under baseline of the sum of diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions.
Time Frame	At baseline, every 6 weeks until radiological disease progression has been documented or the participant begins a subsequent anticancer therapy, up to 22.7 months

Outcome Measure Data

Analysis Population Description

All randomized participants where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.

Arm/Group Title	Figitumumab + Paclitaxel and Carboplatin	Paclitaxel and Carboplatin (Chemo)
Arm/Group Description	Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.	Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
Measure Participants	342	339
Number (95% Confidence Interval) [percentage of participants]	33.0 9.6%	34.5 10.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Figitumumab + Paclitaxel and Carboplatin, Paclitaxel and Carboplatin (Chemo)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.685
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Risk difference
	Estimated Value	-1.472
	Confidence Interval	(2-Sided) 95%; -8.6 to 5.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	Risk difference confidence interval was calculated based on a normal distribution.

4. Secondary Outcome

Title	European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)
Description	EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.
Time Frame	Day 1 of every cycle (3-week cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months

Outcome Measure Data

Analysis Population Description

Due to futility, the study was terminated early; therefore these data were not analyzed.

Arm/Group Title	Figitumumab + Paclitaxel and Carboplatin	Paclitaxel and Carboplatin (Chemo)
Arm/Group Description	Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.	Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
Measure Participants	0	0

5. Secondary Outcome

Title	European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13) Score
Description	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.
Time Frame	Day 1 of every cycle (3-week cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months

Outcome Measure Data

Analysis Population Description

Due to futility, the study was terminated early; therefore these data were not analyzed.

Arm/Group Title	Figitumumab + Paclitaxel and Carboplatin	Paclitaxel and Carboplatin (Chemo)
Arm/Group Description	Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.	Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
Measure Participants	0	0

6. Secondary Outcome

Title	Euro Quality of Life (EQ-5D)- Health State Profile Utility Score
Description	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range of -0.594 to 1; higher score indicates a better health state.
Time Frame	Day 1 of every cycle (3-weeks cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months

Outcome Measure Data

Analysis Population Description

Due to futility, the study was terminated early; therefore EQ-5D data were not analyzed.

Arm/Group Title	Figitumumab + Paclitaxel and Carboplatin	Paclitaxel and Carboplatin (Chemo)
Arm/Group Description	Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.	Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
Measure Participants	0	0

7. Secondary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) for Figitumumab
Time Frame	Cycle 1, Day 1 (predose and 1 hour after end of infusion); Day 1 of Cycles 2, 4, 6 (predose); Cycle 5 Day 1 (predose, 1 hour after end of infusion); 28 days and 150 days after the last figi dose

Outcome Measure Data

Analysis Population Description

This study was terminated early due to futility. As such, Cmax was not summarized.

Arm/Group Title	Figitumumab + Paclitaxel and Carboplatin
Arm/Group Description	Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
Measure Participants	0

8. Secondary Outcome

Title	Minimum Observed Plasma Trough Concentration (Cmin)for Figitumumab
Time Frame	Cycle 1, Day 1 (predose and 1 hour after end of infusion); Day 1 of Cycles 2, 4, 6 (predose); Cycle 5 Day 1 (predose, 1 hour after end of infusion); 28 days and 150 days after the last figi dose

Outcome Measure Data

Analysis Population Description

This study was terminated early due to futility. As such, Cmin was not summarized.

Arm/Group Title	Figitumumab + Paclitaxel and Carboplatin	Paclitaxel and Carboplatin (Chemo)
Arm/Group Description	Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.	Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
Measure Participants	0	0

9. Secondary Outcome

Title	Number of Participants With Total Anti-drug Antibodies (ADA)
Description	ADAs are immunogenicity indicators to figitumumab. Participants reporting positive for ADAs are indicated by an endpoint titer of no less than 6.64.
Time Frame	Cycles 1, 2, and 4 (predose); 28 days and 150 days after the last figi dose

Outcome Measure Data

Analysis Population Description

All participants who received figitumumab (CP-751,871).

Arm/Group Title	Figitumumab + Paclitaxel and Carboplatin	Paclitaxel and Carboplatin (Chemo)
Arm/Group Description	Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.	Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
Measure Participants	332	32
Number [participants]	2 0.6%	0 0%

10. Secondary Outcome

Title	Change From Baseline in Serum Insulin Growth Factor 1 (IGF1) Levels
Time Frame	Cycles 1 and 4 (predose) and at end of treatment

Outcome Measure Data

Analysis Population Description

This study was terminated early due to futility. As such, these data were not analyzed.

Arm/Group Title	Figitumumab + Paclitaxel and Carboplatin	Paclitaxel and Carboplatin (Chemo)
Arm/Group Description	Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.	Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
Measure Participants	0	0

Adverse Events

Adverse Event Reporting Description	Distinct events are presented. An event may be categorized as serious in 1 subject and as nonserious in another, or 1 subject may have experienced both kinds of events. The 1 participant who was randomized to receive figi and chemo but was treated only with chemo is included under the chemo group. Only treated participants are included.
Arm/Group Title	Figitumumab + Paclitaxel and Carboplatin		Paclitaxel and Carboplatin (Chemo)
Arm/Group Description	Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.		Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
All Cause Mortality
	Figitumumab + Paclitaxel and Carboplatin		Paclitaxel and Carboplatin (Chemo)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Figitumumab + Paclitaxel and Carboplatin		Paclitaxel and Carboplatin (Chemo)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	223/338 (66%)		170/333 (51.1%)
Blood and lymphatic system disorders
Anaemia	2/338 (0.6%)		9/333 (2.7%)
Bone marrow failure	1/338 (0.3%)		0/333 (0%)
Febrile bone marrow aplasia	0/338 (0%)		1/333 (0.3%)
Febrile neutropenia	5/338 (1.5%)		11/333 (3.3%)
Granulocytopenia	1/338 (0.3%)		2/333 (0.6%)
Leukopenia	1/338 (0.3%)		1/333 (0.3%)
Neutropenia	5/338 (1.5%)		1/333 (0.3%)
Pancytopenia	2/338 (0.6%)		0/333 (0%)
Thrombocytopenia	2/338 (0.6%)		5/333 (1.5%)
Cardiac disorders
Angina pectoris	1/338 (0.3%)		1/333 (0.3%)
Arrhythmia	1/338 (0.3%)		0/333 (0%)
Atrial fibrillation	1/338 (0.3%)		1/333 (0.3%)
Cardiac arrest	1/338 (0.3%)		0/333 (0%)
Cardiac failure	1/338 (0.3%)		1/333 (0.3%)
Cardiac failure congestive	0/338 (0%)		1/333 (0.3%)
Cardio-respiratory arrest	1/338 (0.3%)		1/333 (0.3%)
Cardiopulmonary failure	3/338 (0.9%)		1/333 (0.3%)
Cardiotoxicity	1/338 (0.3%)		0/333 (0%)
Cardiovascular disorder	2/338 (0.6%)		0/333 (0%)
Myocardial infarction	2/338 (0.6%)		2/333 (0.6%)
Myocardial ischaemia	2/338 (0.6%)		0/333 (0%)
Tachyarrhythmia	1/338 (0.3%)		0/333 (0%)
Ear and labyrinth disorders
Vertigo	1/338 (0.3%)		0/333 (0%)
Endocrine disorders
Adrenal insufficiency	1/338 (0.3%)		0/333 (0%)
Inappropriate antidiuretic hormone secretion	1/338 (0.3%)		0/333 (0%)
Gastrointestinal disorders
Abdominal pain	1/338 (0.3%)		0/333 (0%)
Abdominal pain upper	1/338 (0.3%)		0/333 (0%)
Anal fistula	1/338 (0.3%)		0/333 (0%)
Diarrhoea	9/338 (2.7%)		0/333 (0%)
Duodenal ulcer	0/338 (0%)		1/333 (0.3%)
Dysphagia	1/338 (0.3%)		1/333 (0.3%)
Gastric disorder	1/338 (0.3%)		0/333 (0%)
Gastric perforation	1/338 (0.3%)		0/333 (0%)
Gastrointestinal haemorrhage	2/338 (0.6%)		1/333 (0.3%)
Glossitis	1/338 (0.3%)		0/333 (0%)
Haematemesis	0/338 (0%)		1/333 (0.3%)
Haemorrhoids	1/338 (0.3%)		0/333 (0%)
Nausea	3/338 (0.9%)		2/333 (0.6%)
Oesophageal perforation	1/338 (0.3%)		0/333 (0%)
Oesophagitis	1/338 (0.3%)		0/333 (0%)
Peptic ulcer	0/338 (0%)		1/333 (0.3%)
Stomatitis	1/338 (0.3%)		0/333 (0%)
Upper gastrointestinal haemorrhage	1/338 (0.3%)		0/333 (0%)
Vomiting	7/338 (2.1%)		1/333 (0.3%)
General disorders
Adverse drug reaction	0/338 (0%)		1/333 (0.3%)
Asthenia	11/338 (3.3%)		2/333 (0.6%)
Chest pain	3/338 (0.9%)		0/333 (0%)
Condition aggravated	1/338 (0.3%)		0/333 (0%)
Death	3/338 (0.9%)		3/333 (0.9%)
Disease progression	115/338 (34%)		90/333 (27%)
Drug intolerance	0/338 (0%)		2/333 (0.6%)
Fatigue	0/338 (0%)		2/333 (0.6%)
General physical health deterioration	8/338 (2.4%)		5/333 (1.5%)
Malaise	1/338 (0.3%)		1/333 (0.3%)
Multi-organ failure	1/338 (0.3%)		0/333 (0%)
Pain	3/338 (0.9%)		3/333 (0.9%)
Performance status decreased	1/338 (0.3%)		2/333 (0.6%)
Pyrexia	4/338 (1.2%)		4/333 (1.2%)
Sudden death	1/338 (0.3%)		1/333 (0.3%)
Hepatobiliary disorders
Cholecystitis	1/338 (0.3%)		0/333 (0%)
Hyperbilirubinaemia	1/338 (0.3%)		1/333 (0.3%)
Infections and infestations
Anal abscess	1/338 (0.3%)		0/333 (0%)
Bone abscess	0/338 (0%)		1/333 (0.3%)
Bronchitis	1/338 (0.3%)		0/333 (0%)
Bronchopulmonary aspergillosis	1/338 (0.3%)		0/333 (0%)
Candidiasis	1/338 (0.3%)		0/333 (0%)
Cellulitis	1/338 (0.3%)		0/333 (0%)
Diverticulitis	2/338 (0.6%)		0/333 (0%)
Erysipelas	0/338 (0%)		1/333 (0.3%)
Gastroenteritis	1/338 (0.3%)		1/333 (0.3%)
Infection	1/338 (0.3%)		1/333 (0.3%)
Lung abscess	1/338 (0.3%)		1/333 (0.3%)
Lung infection	2/338 (0.6%)		0/333 (0%)
Neutropenic sepsis	1/338 (0.3%)		0/333 (0%)
Oral candidiasis	1/338 (0.3%)		0/333 (0%)
Pneumonia	21/338 (6.2%)		12/333 (3.6%)
Pseudomonas infection	1/338 (0.3%)		0/333 (0%)
Pyothorax	1/338 (0.3%)		0/333 (0%)
Respiratory tract infection	1/338 (0.3%)		1/333 (0.3%)
Sepsis	4/338 (1.2%)		0/333 (0%)
Septic shock	3/338 (0.9%)		1/333 (0.3%)
Sputum purulent	1/338 (0.3%)		0/333 (0%)
Staphylococcal infection	1/338 (0.3%)		0/333 (0%)
Urinary tract infection	0/338 (0%)		2/333 (0.6%)
Injury, poisoning and procedural complications
Fall	1/338 (0.3%)		1/333 (0.3%)
Femoral neck fracture	0/338 (0%)		1/333 (0.3%)
Hip fracture	3/338 (0.9%)		0/333 (0%)
Overdose	1/338 (0.3%)		0/333 (0%)
Poisoning	0/338 (0%)		1/333 (0.3%)
Scapula fracture	1/338 (0.3%)		0/333 (0%)
Toxicity to various agents	1/338 (0.3%)		0/333 (0%)
Investigations
Blood creatinine increased	1/338 (0.3%)		1/333 (0.3%)
Blood glucose increased	1/338 (0.3%)		0/333 (0%)
Eastern Cooperative Oncology Group performance status worsened	0/338 (0%)		1/333 (0.3%)
General physical condition abnormal	1/338 (0.3%)		0/333 (0%)
Haemoglobin decreased	0/338 (0%)		2/333 (0.6%)
Platelet count decreased	1/338 (0.3%)		0/333 (0%)
Weight decreased	2/338 (0.6%)		0/333 (0%)
Metabolism and nutrition disorders
Cachexia	1/338 (0.3%)		0/333 (0%)
Decreased appetite	5/338 (1.5%)		0/333 (0%)
Dehydration	15/338 (4.4%)		2/333 (0.6%)
Diabetes mellitus	1/338 (0.3%)		0/333 (0%)
Failure to thrive	1/338 (0.3%)		0/333 (0%)
Hypercalcaemia	3/338 (0.9%)		2/333 (0.6%)
Hyperglycaemia	11/338 (3.3%)		1/333 (0.3%)
Hyperkalaemia	1/338 (0.3%)		0/333 (0%)
Hypoglycaemia	0/338 (0%)		1/333 (0.3%)
Hypokalaemia	2/338 (0.6%)		0/333 (0%)
Hyponatraemia	1/338 (0.3%)		1/333 (0.3%)
Malnutrition	0/338 (0%)		1/333 (0.3%)
Type 2 diabetes mellitus	1/338 (0.3%)		0/333 (0%)
Musculoskeletal and connective tissue disorders
Back pain	1/338 (0.3%)		1/333 (0.3%)
Pain in extremity	2/338 (0.6%)		1/333 (0.3%)
Pathological fracture	1/338 (0.3%)		0/333 (0%)
Rhabdomyolysis	1/338 (0.3%)		0/333 (0%)
Systemic lupus erythematosus	0/338 (0%)		1/333 (0.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas	0/338 (0%)		1/333 (0.3%)
Genitourinary tract neoplasm	1/338 (0.3%)		0/333 (0%)
Lung cancer metastatic	1/338 (0.3%)		0/333 (0%)
Lung neoplasm malignant	3/338 (0.9%)		0/333 (0%)
Metastases to central nervous system	1/338 (0.3%)		0/333 (0%)
Metastases to meninges	1/338 (0.3%)		0/333 (0%)
Non-small cell lung cancer	2/338 (0.6%)		3/333 (0.9%)
Tongue neoplasm malignant stage unspecified	1/338 (0.3%)		0/333 (0%)
Nervous system disorders
Cerebral haemorrhage	0/338 (0%)		1/333 (0.3%)
Cerebral infarction	1/338 (0.3%)		1/333 (0.3%)
Cerebrovascular accident	2/338 (0.6%)		3/333 (0.9%)
Convulsion	2/338 (0.6%)		0/333 (0%)
Dizziness	1/338 (0.3%)		0/333 (0%)
Hemiparesis	1/338 (0.3%)		1/333 (0.3%)
Hydrocephalus	1/338 (0.3%)		0/333 (0%)
Ischaemic stroke	0/338 (0%)		1/333 (0.3%)
Lethargy	1/338 (0.3%)		0/333 (0%)
Neuropathy peripheral	1/338 (0.3%)		2/333 (0.6%)
Neurotoxicity	1/338 (0.3%)		0/333 (0%)
Spinal cord compression	1/338 (0.3%)		0/333 (0%)
Syncope	2/338 (0.6%)		1/333 (0.3%)
Tremor	1/338 (0.3%)		0/333 (0%)
Psychiatric disorders
Completed suicide	0/338 (0%)		1/333 (0.3%)
Confusional state	3/338 (0.9%)		0/333 (0%)
Delirium	1/338 (0.3%)		1/333 (0.3%)
Depression	1/338 (0.3%)		0/333 (0%)
Hallucination	1/338 (0.3%)		0/333 (0%)
Insomnia	1/338 (0.3%)		0/333 (0%)
Mental status changes	2/338 (0.6%)		0/333 (0%)
Renal and urinary disorders
Haematuria	0/338 (0%)		1/333 (0.3%)
Renal colic	1/338 (0.3%)		0/333 (0%)
Renal failure	2/338 (0.6%)		2/333 (0.6%)
Renal failure acute	2/338 (0.6%)		1/333 (0.3%)
Renal impairment	1/338 (0.3%)		0/333 (0%)
Urinary retention	1/338 (0.3%)		0/333 (0%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	2/338 (0.6%)		1/333 (0.3%)
Asphyxia	0/338 (0%)		1/333 (0.3%)
Chronic obstructive pulmonary disease	2/338 (0.6%)		1/333 (0.3%)
Cough	0/338 (0%)		1/333 (0.3%)
Dyspnoea	6/338 (1.8%)		6/333 (1.8%)
Dyspnoea exertional	1/338 (0.3%)		0/333 (0%)
Emphysema	1/338 (0.3%)		0/333 (0%)
Epistaxis	0/338 (0%)		1/333 (0.3%)
Haemoptysis	9/338 (2.7%)		5/333 (1.5%)
Hydropneumothorax	1/338 (0.3%)		0/333 (0%)
Hydrothorax	1/338 (0.3%)		0/333 (0%)
Hypoxia	1/338 (0.3%)		0/333 (0%)
Lung disorder	1/338 (0.3%)		1/333 (0.3%)
Mediastinal disorder	1/338 (0.3%)		0/333 (0%)
Obstructive airways disorder	0/338 (0%)		1/333 (0.3%)
Pleural effusion	1/338 (0.3%)		2/333 (0.6%)
Pneumomediastinum	1/338 (0.3%)		0/333 (0%)
Pneumonia aspiration	1/338 (0.3%)		1/333 (0.3%)
Pneumonitis	1/338 (0.3%)		0/333 (0%)
Pneumothorax	2/338 (0.6%)		1/333 (0.3%)
Pulmonary embolism	7/338 (2.1%)		6/333 (1.8%)
Pulmonary haemorrhage	2/338 (0.6%)		1/333 (0.3%)
Pulmonary oedema	0/338 (0%)		1/333 (0.3%)
Respiratory failure	2/338 (0.6%)		2/333 (0.6%)
Skin and subcutaneous tissue disorders
Rash	1/338 (0.3%)		0/333 (0%)
Vascular disorders
Arterial thrombosis limb	0/338 (0%)		1/333 (0.3%)
Arteritis	0/338 (0%)		1/333 (0.3%)
Deep vein thrombosis	1/338 (0.3%)		2/333 (0.6%)
Haemorrhage	2/338 (0.6%)		0/333 (0%)
Hypotension	3/338 (0.9%)		0/333 (0%)
Hypovolaemic shock	1/338 (0.3%)		0/333 (0%)
Orthostatic hypotension	1/338 (0.3%)		0/333 (0%)
Superior vena cava syndrome	0/338 (0%)		1/333 (0.3%)
Thrombosis	1/338 (0.3%)		1/333 (0.3%)
Vena cava thrombosis	1/338 (0.3%)		0/333 (0%)
Other (Not Including Serious) Adverse Events
	Figitumumab + Paclitaxel and Carboplatin		Paclitaxel and Carboplatin (Chemo)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	316/338 (93.5%)		303/333 (91%)
Blood and lymphatic system disorders
Anaemia	93/338 (27.5%)		85/333 (25.5%)
Leukopenia	18/338 (5.3%)		33/333 (9.9%)
Neutropenia	74/338 (21.9%)		78/333 (23.4%)
Thrombocytopenia	60/338 (17.8%)		49/333 (14.7%)
Gastrointestinal disorders
Constipation	60/338 (17.8%)		61/333 (18.3%)
Diarrhoea	95/338 (28.1%)		45/333 (13.5%)
Dysphagia	18/338 (5.3%)		9/333 (2.7%)
Nausea	132/338 (39.1%)		101/333 (30.3%)
Stomatitis	30/338 (8.9%)		10/333 (3%)
Vomiting	82/338 (24.3%)		46/333 (13.8%)
General disorders
Asthenia	71/338 (21%)		59/333 (17.7%)
Chest pain	45/338 (13.3%)		34/333 (10.2%)
Fatigue	112/338 (33.1%)		85/333 (25.5%)
Mucosal inflammation	27/338 (8%)		9/333 (2.7%)
Oedema peripheral	10/338 (3%)		24/333 (7.2%)
Pyrexia	26/338 (7.7%)		33/333 (9.9%)
Investigations
Weight decreased	65/338 (19.2%)		29/333 (8.7%)
Metabolism and nutrition disorders
Decreased appetite	128/338 (37.9%)		75/333 (22.5%)
Dehydration	28/338 (8.3%)		10/333 (3%)
Hyperglycaemia	74/338 (21.9%)		16/333 (4.8%)
Hyperkalaemia	17/338 (5%)		5/333 (1.5%)
Musculoskeletal and connective tissue disorders
Arthralgia	47/338 (13.9%)		57/333 (17.1%)
Back pain	19/338 (5.6%)		19/333 (5.7%)
Muscle spasms	19/338 (5.6%)		5/333 (1.5%)
Musculoskeletal pain	20/338 (5.9%)		17/333 (5.1%)
Myalgia	39/338 (11.5%)		44/333 (13.2%)
Pain in extremity	33/338 (9.8%)		23/333 (6.9%)
Nervous system disorders
Dizziness	37/338 (10.9%)		32/333 (9.6%)
Dysgeusia	26/338 (7.7%)		13/333 (3.9%)
Headache	37/338 (10.9%)		22/333 (6.6%)
Neuropathy peripheral	63/338 (18.6%)		56/333 (16.8%)
Paraesthesia	29/338 (8.6%)		35/333 (10.5%)
Peripheral sensory neuropathy	40/338 (11.8%)		50/333 (15%)
Psychiatric disorders
Anxiety	17/338 (5%)		17/333 (5.1%)
Insomnia	32/338 (9.5%)		30/333 (9%)
Respiratory, thoracic and mediastinal disorders
Cough	66/338 (19.5%)		59/333 (17.7%)
Dyspnoea	56/338 (16.6%)		65/333 (19.5%)
Epistaxis	26/338 (7.7%)		3/333 (0.9%)
Haemoptysis	32/338 (9.5%)		21/333 (6.3%)
Skin and subcutaneous tissue disorders
Alopecia	138/338 (40.8%)		146/333 (43.8%)
Pruritus	26/338 (7.7%)		18/333 (5.4%)
Rash	28/338 (8.3%)		20/333 (6%)

Limitations/Caveats

The study was terminated early due to futility. CP-751,871 will not undergo further development in the indication of advanced non-adenocarcinoma non-small cell lung cancer (NSCLC).

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.