PACIFIC-4: Durvalumab vs Placebo With Stereotactic Body Radiation Therapy in Early Stage Unresected Non-small Cell Lung Cancer (NSCLC) Patients / Osimertinib Following SBRT in Patients With Early Stage Unresected NSCLC Harboring an EGFR Mutation

• Sponsor: AstraZeneca (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT03833154
• Collaborator: (none)
• Enrollment: 733
• Locations: 245
• Arms: 3
• Anticipated Duration (Months): 106.9
• Patients Per Site: 3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This is a Phase III, randomized, placebo-controlled, double-blind, multi-center study assessing the efficacy and safety of durvalumab with SoC SBRT versus placebo with SoC SBRT in patients with unresected clinical Stage I/II lymph node-negative (T1 to T3N0M0) NSCLC.

An additional cohort will assess Osimertinib following SBRT in patients with early stage unresected T1 to T3N0M0 NSCLC harbouring an EGFR mutation.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Non-Small-Cell Lung	Drug: Durvalumab; Other: Placebo; Drug: Osimertinib (single-arm, open-label)	Phase 3

Detailed Description

Patients who are to receive SoC SBRT as definitive treatment of Stage I/II lymph node-negative NSCLC and confirmed to meet all eligibility criteria will be randomized 1:1 to Durvalumab or placebo.

The primary objective of main cohort is to assess the efficacy of Durvalumab with SoC SBRT compared to placebo with SoC SBRT in terms of PFS. Key secondary is to assess the efficacy of Durvalumab with SoC SBRT compared to placebo with SoC SBRT in terms of Overall Survival (OS).

In addition, a study cohort with a sufficient number of patients harboring an EGFR mutation, will receive Osimertinib treatment after completion of SoC SBRT as definitive treatment of Stage I/II lymph node-negative NSCLC. The primary objective of Osimertinib cohort is to assess efficacy of Osimertinib following SoC SBRT in terms of 4years-PFS. Key secondary objectives include safety, OS and efficacy of Osimertininb treatment with SBRT.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 733 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Double- Blind
• Primary Purpose: Treatment
• Official Title: A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab With Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients With Unresected Stage I/II, Lymph-node Negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515) Osimertinib Following SBRT, a Single Arm Cohort for Patients With Unresected Stage I/II, Lymph Node Negative NSCLC Harboring a Sensitizing EGFR Mutation
• Actual Study Start Date: Mar 6, 2019
• Anticipated Primary Completion Date: Jun 23, 2025
• Anticipated Study Completion Date: Jan 31, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SoC SBRT + Durvalumab Therapy (Main Cohort) SBRT - delivered in 3, 4, 5 or 8 fractions. Durvalumab (PD-L1 monoclonal antibody) 1500 mg every 4 weeks [q4w] intravenously [iv] for up to 24 months or until progression or other discontinuation criteria are met.	Drug: Durvalumab; Durvalumab 1500 mg every 4 weeks [q4w] intravenously [iv] for up to 24 months or until progression or other discontinuation criteria are met.; Other Names: MEDI4736
Placebo Comparator: SoC SBRT + Placebo Therapy (Main Cohort) SBRT - delivered in 3, 4, 5 or 8 fractions. Placebo (matching placebo for infusion every 4 weeks iv for up to 24 months or until progression or other discontinuation criteria are met.	Other: Placebo; Matching placebo for infusion every 4 weeks iv for up to 24 months or until progression or other discontinuation criteria are met.
Experimental: SoC SBRT + Osimertinib Therapy (Osimertinib cohort, single-arm, separate cohort) SBRT delivered in 3, 4, 5 or 8 fractions Osimertinib 80mg every day [qd] for oral administration up to 36 months or until progression. Osimertinib treatment should start within 7 to 14 days after completion of SBRT	Drug: Osimertinib (single-arm, open-label); Osimertinib 80 mg every day [qd] orally for up to 36 months or until progression or other discontinuation criteria are met. Osimertinib treatment should start from 7 to 14 days after completion of SBRT

Outcome Measures

Primary Outcome Measures

1. Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1 in subpopulation of patients with Stage I/II NSCLC [from randomization up to 6 years]

   Main Cohort

2. 4-year Progression-Free Survival (4y-PFS) by ICR according to RECIST 1.1 criteria [from randomization up to 5 years]

   Osimertinib Cohort

Secondary Outcome Measures

1. Progression-Free Survival (PFS) assessed by BICR per RECIST 1.1 in all randomised patients with Stage I/II NSCLC [from randomization up to 6 years]

   Main Cohort

2. Overall Survival (OS) [from randomization up to 7 years]

   Main Cohort

3. Lung cancer-specific mortality [from randomization up to 7 years]

   Main Cohort

4. Maximum Plasma concentration (Cmax) [12 weeks after last dose]

   Main Cohort

5. Detection of ADA neutralising antibodies titers [up to 6 months after last dose]

   Main Cohort

6. Health-related quality of life in patients treated with durvalumab with SoC SBRT compared to placebo with SoC SBRT using the EORTC QLQ-C30 [from randomization up to 7 years]

   Main Cohort

7. Proportion of patients alive and progression free at 24 months from randomisation (PFS24) assessed by BICR according to RECIST 1.1 [at 24 months following randomization]

   Main Cohort

8. Time to progression (TTP) assessed by BICR according to RECIST 1.1 [from randomization up to 6 years]

   Main Cohort

9. Time to death or distant metastasis (TTDM) assessed by BICR according to RECIST 1.1 [from randomization up to 6 years]

   Main Cohort

10. Time from randomisation to second progression (PFS2) as defined by local standard clinical practice [from randomization up to 7 years]

    Main Cohort

11. Trough Concentration (Ctrough) [up to 3 months after last dose]

    Main Cohort

12. Assessment of AEs by CTCAE v 5.0 as measures of the safety and tolerability of Durvalumab with SoC SBRT compared to placebo with SoC SBRT [up to 3 months after last dose]

    Main Cohort

13. Assessment of AEs by CTCAE v 5.0 as measures of the safety, tolerability and compliance of osimertinib with SoC SBRT therapy [Up to 35 days after last dose]

    Osimertinib Cohort

14. WHO performance status [from randomization Up to 5 years]

    Osimertinib Cohort

15. ECG QT interval [Up to 156 weeks of treatment or treatment discontinuation]

    Osimertinib Cohort

16. Overall Survival [from randomization Up to 5 years]

    Osimertinib Cohort

17. Lung cancer mortality [from randomization Up to 5 years]

    Osimertinib Cohort

18. Time To Progression (TTP) [from randomization Up to 5 years]

    Osimertinib Cohort

19. Time to CNS progression [from randomization Up to 5 years]

    Osimertinib Cohort

20. PFS2 [from randomization up to 5 years]

    Osimertinib Cohort

21. Site(s) of disease progression [from randomization up to 5 years]

    Osimertinib Cohort

22. PFS by ICR using RECIST 1.1 [from randomization up to 5 years]

    Osimertinib Cohort

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 130 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Main Cohort Key Inclusion Criteria:

1. Age ≥18 years

2. Planned SoC SBRT as definitive treatment

3. WHO/ECOG PS of 0, 1 or 2

4. Life expectancy of at least 12 weeks

5. Body weight >30 kg

6. Submission of tumor tissue sample if available

7. Adequate organ and marrow function required

8. Patients with central or peripheral lesions are eligible

9. Staging studies must be done during screening (PET-CT within 10 weeks)

10. Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions

Main Cohort Key Exclusion Criteria:

1. Mixed small cell and non-small cell cancer

2. History of allogeneic organ transplantation

3. History of another primary malignancy with exceptions

4. History of active primary immunodeficiency

5. Epidermal growth factor receptor local testing is strongly recommended prior to enrollment. Patients with a tumor harboring an EGFRm per local testing will be excluded from the main cohort

6. Prior exposure to immune-mediated therapy with exceptions

Osimertinib Cohort Key Inclusion Criteria

1. Age ≥18 years

2. Planned SoC SBRT as definitive treatment

3. World Health Organization (WHO)/ECOG PS of 0, 1, or 2

4. Patients with central or peripheral lesions are eligible

5. Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions

6. Staging studies must be done during screening (PET-CT within 10 weeks)

7. Submission of available tumor tissue sample

8. Confirmation by local laboratory that the tumor harbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R)

9. Adequate bone marrow reserve or organ function required

10. Female patients should be using highly effective contraceptive measures

11. Male patients should be asked to use barrier contraceptives (ie, condoms) during sex with all partners during the trial and avoid procreation

Osimertinib Cohort Key Exclusion Criteria

1. Mixed small cell and non-small cell cancer

2. Patients currently receiving potent inducers of CYP3A4

3. Patients with known or increased risk factor for QTc prolongation

4. Treatment with any of the following:

• Preoperative or adjuvant platinum-based or other chemotherapy for the disease under investigation

• Prior treatment with neoadjuvant or adjuvant EGFR TKI

• Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4

• Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib

1. Any of the following cardiac criteria

• Mean resting corrected QT interval >470 msec, obtained from 3 ECGs

• Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG.

• Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, or unexplained -sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval

• Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Tuscaloosa	Alabama	United States	35401
2	Research Site	Chandler	Arizona	United States	85224
3	Research Site	Goodyear	Arizona	United States	85338
4	Research Site	Phoenix	Arizona	United States	85004
5	Research Site	Tucson	Arizona	United States	85719
6	Research Site	Arroyo Grande	California	United States	93420
7	Research Site	Duarte	California	United States	91010
8	Research Site	La Jolla	California	United States	92037
9	Research Site	Long Beach	California	United States	90806
10	Research Site	Los Angeles	California	United States	90073
11	Research Site	Los Angeles	California	United States	90095
12	Research Site	Newport Beach	California	United States	92663
13	Research Site	Palm Springs	California	United States	92262
14	Research Site	Roseville	California	United States	95661
15	Research Site	Sacramento	California	United States	95816
16	Research Site	San Diego	California	United States	92123
17	Research Site	Newark	Delaware	United States	10709
18	Research Site	Washington	District of Columbia	United States	20010
19	Research Site	Bay Pines	Florida	United States	33744
20	Research Site	Jacksonville	Florida	United States	32256
21	Research Site	Miami Beach	Florida	United States	33140
22	Research Site	Orlando	Florida	United States	32804
23	Research Site	Vero Beach	Florida	United States	32960
24	Research Site	Weston	Florida	United States	33331
25	Research Site	Atlanta	Georgia	United States	30322
26	Research Site	Atlanta	Georgia	United States	30342
27	Research Site	Columbus	Georgia	United States	31904
28	Research Site	Chicago	Illinois	United States	60611
29	Research Site	Chicago	Illinois	United States	60612
30	Research Site	Chicago	Illinois	United States	60637
31	Research Site	Decatur	Illinois	United States	62526
32	Research Site	Elmhurst	Illinois	United States	60126
33	Research Site	Geneva	Illinois	United States	60134
34	Research Site	Naperville	Illinois	United States	60540
35	Research Site	Niles	Illinois	United States	60714
36	Research Site	Park Ridge	Illinois	United States	60068
37	Research Site	Springfield	Illinois	United States	62703
38	Research Site	Warrenville	Illinois	United States	60555
39	Research Site	Fort Wayne	Indiana	United States	46845
40	Research Site	Cedar Rapids	Iowa	United States	52403
41	Research Site	Iowa City	Iowa	United States	52242
42	Research Site	Elizabethtown	Kentucky	United States	42701
43	Research Site	Lexington	Kentucky	United States	40503
44	Research Site	Louisville	Kentucky	United States	40202
45	Research Site	Metairie	Louisiana	United States	70006
46	Research Site	New Orleans	Louisiana	United States	70121
47	Research Site	South Portland	Maine	United States	04106
48	Research Site	Annapolis	Maryland	United States	21401
49	Research Site	Baltimore	Maryland	United States	21201
50	Research Site	Berlin	Maryland	United States	21811
51	Research Site	Rosedale	Maryland	United States	21237
52	Research Site	Salisbury	Maryland	United States	21801
53	Research Site	Silver Spring	Maryland	United States	20910
54	Research Site	Towson	Maryland	United States	21204
55	Research Site	Boston	Massachusetts	United States	02215
56	Research Site	Ann Arbor	Michigan	United States	48197
57	Research Site	Detroit	Michigan	United States	48201
58	Research Site	Detroit	Michigan	United States	48201
59	Research Site	Flint	Michigan	United States	48532
60	Research Site	Royal Oak	Michigan	United States	48073
61	Research Site	Duluth	Minnesota	United States	55805
62	Research Site	Minneapolis	Minnesota	United States	55416
63	Research Site	Rochester	Minnesota	United States	55905
64	Research Site	Saint Louis	Missouri	United States	63110
65	Research Site	Lincoln	Nebraska	United States	68510
66	Research Site	Omaha	Nebraska	United States	68105
67	Research Site	Omaha	Nebraska	United States	68114
68	Research Site	Las Vegas	Nevada	United States	89135
69	Research Site	Lebanon	New Hampshire	United States	03756
70	Research Site	East Brunswick	New Jersey	United States	08816
71	Research Site	Paramus	New Jersey	United States	07652
72	Research Site	Albany	New York	United States	12206
73	Research Site	Bronx	New York	United States	10461
74	Research Site	Bronx	New York	United States	10467
75	Research Site	East Syracuse	New York	United States	13057
76	Research Site	New Hyde Park	New York	United States	11042
77	Research Site	New York	New York	United States	10016
78	Research Site	New York	New York	United States	10065
79	Research Site	Rochester	New York	United States	14642
80	Research Site	Stony Brook	New York	United States	11794
81	Research Site	Syracuse	New York	United States	13210
82	Research Site	Chapel Hill	North Carolina	United States	27599
83	Research Site	Durham	North Carolina	United States	27710
84	Research Site	Winston-Salem	North Carolina	United States	27157
85	Research Site	Grand Forks	North Dakota	United States	58201
86	Research Site	Akron	Ohio	United States	44304
87	Research Site	Cincinnati	Ohio	United States	45219
88	Research Site	Cincinnati	Ohio	United States	45242
89	Research Site	Cleveland	Ohio	United States	44106
90	Research Site	Tulsa	Oklahoma	United States	74133
91	Research Site	Eugene	Oregon	United States	97401
92	Research Site	Portland	Oregon	United States	97210
93	Research Site	Portland	Oregon	United States	97213
94	Research Site	Philadelphia	Pennsylvania	United States	19104
95	Research Site	Philadelphia	Pennsylvania	United States	19107
96	Research Site	Pittsburgh	Pennsylvania	United States	15212
97	Research Site	Charleston	South Carolina	United States	29425
98	Research Site	Sioux Falls	South Dakota	United States	57105
99	Research Site	Watertown	South Dakota	United States	57201
100	Research Site	Austin	Texas	United States	78745
101	Research Site	Dallas	Texas	United States	75235
102	Research Site	Houston	Texas	United States	77030
103	Research Site	Houston	Texas	United States	77030
104	Research Site	Sherman	Texas	United States	75090
105	Research Site	Burlington	Vermont	United States	05401
106	Research Site	Richmond	Virginia	United States	23230
107	Research Site	Richmond	Virginia	United States	23249
108	Research Site	Richmond	Virginia	United States	23298
109	Research Site	Bellingham	Washington	United States	98225
110	Research Site	Kennewick	Washington	United States	99336
111	Research Site	Kirkland	Washington	United States	98034
112	Research Site	Seattle	Washington	United States	98195
113	Research Site	Spokane Valley	Washington	United States	99216
114	Research Site	Vancouver	Washington	United States	98684
115	Research Site	Morgantown	West Virginia	United States	26506
116	Research Site	Milwaukee	Wisconsin	United States	53212
117	Research Site	Milwaukee	Wisconsin	United States	53226
118	Research Site	Aalst		Belgium	9300
119	Research Site	Charleroi		Belgium	6000
120	Research Site	Edegem		Belgium	2650
121	Research Site	Gent		Belgium	9000
122	Research Site	Leuven		Belgium	3000
123	Research Site	Calgary	Alberta	Canada	T2N 4N2
124	Research Site	Edmonton	Alberta	Canada	T6G 1Z2
125	Research Site	London	Ontario	Canada	N6A 5W9
126	Research Site	Toronto	Ontario	Canada	M4N 3M5
127	Research Site	Toronto	Ontario	Canada	M5G 2M9
128	Research Site	Montreal	Quebec	Canada	H2X 3E4
129	Research Site	Beijing		China	100021
130	Research Site	Beijing		China	100029
131	Research Site	Beijing		China	100142
132	Research Site	Changchun		China	130021
133	Research Site	Changsha		China	410013
134	Research Site	Chengdu		China	610042
135	Research Site	Fuzhou		China	350005
136	Research Site	Hangzhou		China	310002
137	Research Site	Hangzhou		China	310022
138	Research Site	Hefei		China	230031
139	Research Site	Jinan		China	2501117
140	Research Site	Nanjing		China	210009
141	Research Site	Shanghai		China	200002
142	Research Site	Shanghai		China	200030
143	Research Site	Shanghai		China	200032
144	Research Site	Shanghai		China	200433
145	Research Site	Shenyang		China	100003
146	Research Site	Suzhou		China	215006
147	Research Site	Wenzhou		China	325000
148	Research Site	Wuhan		China	430022
149	Research Site	Wuhan		China	430030
150	Research Site	Zhengzhou		China	450008
151	Research Site	Bron		France	69677
152	Research Site	Dijon		France	21079
153	Research Site	Lyon Cedex 04		France	69317
154	Research Site	Nantes		France	44202
155	Research Site	Paris		France	75015
156	Research Site	Pierre Benite		France	69310
157	Research Site	Toulouse		France	31000
158	Research Site	Villejuif		France	94805
159	Research Site	Dresden		Germany	01307
160	Research Site	Göttingen		Germany	37075
161	Research Site	Halle		Germany	06120
162	Research Site	Hannover		Germany	30459
163	Research Site	Heidelberg		Germany	69126
164	Research Site	Homburg		Germany	66421
165	Research Site	Mainz		Germany	55131
166	Research Site	München		Germany	81675
167	Research Site	Regensburg		Germany	93053
168	Research Site	Würzburg		Germany	97080
169	Research Site	Haifa		Israel	31096
170	Research Site	Jerusalem		Israel	91120
171	Research Site	Kfar Saba		Israel	95847
172	Research Site	Petah Tikva		Israel	49100
173	Research Site	Ramat Gan		Israel	52621
174	Research Site	Tel Aviv		Israel	64239
175	Research Site	Firenze		Italy	50134
176	Research Site	Genova		Italy	16132
177	Research Site	Milano		Italy	20132
178	Research Site	Orbassano		Italy	10043
179	Research Site	Padova		Italy	35128
180	Research Site	Roma		Italy	00128
181	Research Site	Rozzano		Italy	20089
182	Research Site	Akashi-shi		Japan	673-8558
183	Research Site	Bunkyo-ku		Japan	113-8677
184	Research Site	Chuo-ku		Japan	104-0045
185	Research Site	Fukuoka-shi		Japan	812-8582
186	Research Site	Hirosaki-shi		Japan	036-8563
187	Research Site	Hiroshima-shi		Japan	734-8551
188	Research Site	Kashiwa		Japan	277-8577
189	Research Site	Kobe-shi		Japan	650-0047
190	Research Site	Kyoto-shi		Japan	606-8507
191	Research Site	Niigata-shi		Japan	951-8566
192	Research Site	Osaka-shi		Japan	541-8567
193	Research Site	Sakai-shi		Japan	591-8555
194	Research Site	Sapporo-shi		Japan	060-8648
195	Research Site	Sunto-gun		Japan	411-8777
196	Research Site	Toyoake-shi		Japan	470-1192
197	Research Site	Yokohama-shi		Japan	241-8515
198	Research Site	Cheongju-si		Korea, Republic of	28644
199	Research Site	Goyang-si		Korea, Republic of	10408
200	Research Site	Gyeonggi-do		Korea, Republic of	13620
201	Research Site	Seoul		Korea, Republic of	03722
202	Research Site	Seoul		Korea, Republic of	05505
203	Research Site	Seoul		Korea, Republic of	06351
204	Research Site	Amsterdam		Netherlands	1081 HV
205	Research Site	Groningen		Netherlands	9713 GZ
206	Research Site	Harderwijk		Netherlands	3844 DG
207	Research Site	Maastricht		Netherlands	6202 AZ
208	Research Site	Rotterdam		Netherlands	3079 DZ
209	Research Site	Utrecht		Netherlands	3584 CX
210	Research Site	Białystok		Poland	15-044
211	Research Site	Elbląg		Poland	02-300
212	Research Site	Gdańsk		Poland	80-214
213	Research Site	Katowice		Poland	40-514
214	Research Site	Warszawa		Poland	02-781
215	Research Site	Łódź		Poland	93-513
216	Research Site	Hato Rey		Puerto Rico	00917
217	Research Site	San Juan		Puerto Rico	00927
218	Research Site	Ekaterinburg		Russian Federation	620905
219	Research Site	Kazan, Tatarstan		Russian Federation	420029
220	Research Site	Moscow		Russian Federation	105229
221	Research Site	Moscow		Russian Federation	115478
222	Research Site	Moscow		Russian Federation	119421
223	Research Site	Saint Petersburg		Russian Federation	197758
224	Research Site	Saint-Petersburg		Russian Federation	197758
225	Research Site	St. Petersburg		Russian Federation	197758
226	Research Site	Ufa		Russian Federation	450054
227	Research Site	Badajoz		Spain	6006
228	Research Site	Barcelona		Spain	08041
229	Research Site	L'Hospitalet de Llobregat		Spain	08907
230	Research Site	Madrid		Spain	28034
231	Research Site	Madrid		Spain	28041
232	Research Site	Madrid		Spain	28046
233	Research Site	Malaga		Spain	29010
234	Research Site	San Sebastián		Spain	20014
235	Research Site	Santiago de Compostela		Spain	15706
236	Research Site	Sevilla		Spain	41009
237	Research Site	Valencia		Spain	46010
238	Research Site	Zaragoza		Spain	50009
239	Research Site	Ankara		Turkey	06520
240	Research Site	Istanbul		Turkey	34214
241	Research Site	Izmir		Turkey	35340
242	Research Site	Birmingham		United Kingdom	B9 5SS
243	Research Site	Leeds		United Kingdom	LS9 7TF
244	Research Site	London		United Kingdom	EC1A 7BE
245	Research Site	Manchester		United Kingdom	M20 4BX

Sponsors and Collaborators

• AstraZeneca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT03833154
• Other Study ID Numbers: D9103C00001; 2018-002572-41
• First Posted: Feb 6, 2019
• Last Update Posted: Aug 1, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by AstraZeneca: NSCLC; Early-Stage NSCLC; Lung cancer; Double- Blind; PD-L1; MEDI4736; Durvalumab; Osimertinib; PFS; OS; Unresected lung cancer; Inoperable; Operable; SBRT; SABR; EGFR
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Durvalumab; Osimertinib

Study Results

No Results Posted as of Aug 1, 2022