Phase 1b/2 Trial of AMG386 With Pemetrexed and Carboplatin in Non-Small Cell Lung Cancer

Sponsor

Amgen (Industry)

Overall Status

Completed

CT.gov ID

NCT01666977

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this phase 1b/2 study is to estimate the treatment effect of study drug measuring progression free survival.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	Drug: AMG 386 Drug: AMG 386 Drug: AMG 386 Placebo Drug: Pemetrexed Drug: Carboplatin	Phase 1/Phase 2

Detailed Description

To evaluate the incidence of adverse events and clinical laboratory abnormalities defined as dose-limiting toxicity in subjects with metastatic non-squamous non-small cell lung cancer (NSCLC) treated with AMG 386 in combination with pemetrexed and carboplatin

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase 1b/2 Trial of AMG 386 in Combination With Pemetrexed and Carboplatin as First Line Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer

Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Nov 1, 2015

Actual Study Completion Date :

Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A Arm A: AMG 386 placebo IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles	Drug: AMG 386 Placebo AMG 386 Placebo Drug: Pemetrexed Pemetrexed 500 mg/m2 Drug: Carboplatin Carboplatin AUC 6
Experimental: Arm B Arm B: AMG 386 15 mg/kg IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles	Drug: AMG 386 15mg/kg Drug: Pemetrexed Pemetrexed 500 mg/m2 Drug: Carboplatin Carboplatin AUC 6
Experimental: Arm C Arm C: AMG 386 30 mg/kg IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles	Drug: AMG 386 30 mg/kg Drug: Pemetrexed Pemetrexed 500 mg/m2 Drug: Carboplatin Carboplatin AUC 6

Arm

Intervention/Treatment

Experimental: Arm A

Arm A: AMG 386 placebo IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles

Drug: AMG 386 Placebo

AMG 386 Placebo

Drug: Pemetrexed

Pemetrexed 500 mg/m2

Drug: Carboplatin

Carboplatin AUC 6

Experimental: Arm B

Arm B: AMG 386 15 mg/kg IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles

Drug: AMG 386

15mg/kg

Drug: Pemetrexed

Pemetrexed 500 mg/m2

Drug: Carboplatin

Carboplatin AUC 6

Experimental: Arm C

Arm C: AMG 386 30 mg/kg IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles

Drug: AMG 386

30 mg/kg

Drug: Pemetrexed

Pemetrexed 500 mg/m2

Drug: Carboplatin

Carboplatin AUC 6

Outcome Measures

Primary Outcome Measures

Progression Free Survival [Incidence of adverse events and clinical laboratory abnormalities defined as a DLT]
Subjects will be evaluated for progression free survival.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Histologically confirmed, unresectable stage IV non-squamous non small cell lung cancer (NSCLC)
Radiographically evaluable disease (measurable or non-measurable) per RECIST 1.1 with modifications
Adequate hematological, renal, and hepatic function, normal coagulation profile, calculated CrCL ≥ 45 mL/min
Other criteria may apply

Exclusion Criteria:

Any prior chemotherapy or targeted therapy for non-squamous NSCLC
Subjects with adenosquamous histology or any histology subtype containing greater than 10% squamous cells
Subjects with an epidermal growth factor receptor (EGFR) mutation sensitive to treatment with a tyrosine kinase inhibitor (TKI)
Subjects with known anaplastic lymphoma kinase (EML4-ALK) translocations
History or presence of central nervous system metastases
Central (chest) radiation therapy within 28 days prior to enrollment/randomization, radiation therapy to any other site(s) within 14 days prior to enrollment/randomization
History of pulmonary hemorrhage or gross hemoptysis within 6 months
History of arterial or venous thromboembolism within 12 months
History of clinically significant bleeding within 6 months
Clinically significant cardiovascular disease within 12 months
Other criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Fayetteville	Arkansas	United States	72703
2	Research Site	Hot Springs	Arkansas	United States	71913
3	Research Site	Los Angeles	California	United States	90048
4	Research Site	Palm Springs	California	United States	92262
5	Research Site	Pleasant Hill	California	United States	94523
6	Research Site	San Diego	California	United States	92123
7	Research Site	Santa Monica	California	United States	90403
8	Research Site	Peoria	Illinois	United States	61615
9	Research Site	Paducah	Kentucky	United States	42003
10	Research Site	Hannover	New Hampshire	United States	03756
11	Research Site	Bronx	New York	United States	10461
12	Research Site	Bismarck	North Dakota	United States	58501
13	Research Site	Greenville	South Carolina	United States	29605
14	Research Site	Camperdown	New South Wales	Australia	2050
15	Research Site	Kogarah	New South Wales	Australia	2217
16	Research Site	Randwick	New South Wales	Australia	2031
17	Research Site	Tweed Heads	New South Wales	Australia	2485
18	Research Site	Herston	Queensland	Australia	4029
19	Research Site	Bentleigh East	Victoria	Australia	3165
20	Research Site	Heidelberg	Victoria	Australia	3084
21	Research Site	Bruxelles		Belgium	1200
22	Research Site	Hamilton	Ontario	Canada	L8V 5C2
23	Research Site	Oshawa	Ontario	Canada	L1G 2B9
24	Research Site	Ottawa	Ontario	Canada	K1H 8L6
25	Research Site	Toronto	Ontario	Canada	M4N 3M5
26	Research Site	Laval	Quebec	Canada	H7M 3L9
27	Research Site	Levis	Quebec	Canada	G6V 3Z1
28	Research Site	Montreal	Quebec	Canada	H2L 4M1
29	Research Site	Heraklion		Greece	71110
30	Research Site	Larissa		Greece	41110
31	Research Site	Patra		Greece	26500
32	Research Site	Thessaloniki		Greece	56429
33	Research Site	Málaga	Andalucía	Spain	29010
34	Research Site	Zaragoza	Aragón	Spain	50009
35	Research Site	Madrid		Spain	28046