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CTRI Number  CTRI/2020/09/027739 [Registered on: 10/09/2020] Trial Registered Prospectively
Last Modified On: 31/01/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study of Durvalumab or Placebo given along with Standard Chemotherapy in Patients with Non-small Cell Lung Cancer (Stage II-III) who’s tumor has been removed through surgery 
Scientific Title of Study   A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Study to Determine the Efficacy of Adjuvant Durvalumab in Combination with Platinum-based Chemotherapy in Completely Resected Stage II-III NSCLC (MeRmaiD-1)  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
D910LC00001 Version 1.0 dated 09 MAR 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
 
Name  Mr Tapankumar M Shah 
Designation  Director, Site Management and Monitoring – India 
Affiliation  AstraZeneca Pharma India Ltd 
Address  Block N1, 12th Floor, Manyata Embassy Business Park Rachenahalli, Outer Ring Road. Bangalore

Bangalore
KARNATAKA
560045
India 
Phone  91-9535104975  
Fax  91-8067748857  
Email  tapankumar.shah@astrazeneca.com  
 
Details of Contact Person
Public Query
 
Name  Mr Tapankumar M Shah 
Designation  Director, Site Management and Monitoring – India 
Affiliation  AstraZeneca Pharma India Ltd 
Address  Block N1, 12th Floor, Manyata Embassy Business Park Rachenahalli, Outer Ring Road. Bangalore

Bangalore
KARNATAKA
560045
India 
Phone  91-9535104975  
Fax  91-8067748857  
Email  tapankumar.shah@astrazeneca.com  
 
Source of Monetary or Material Support  
AstraZeneca AB  
 
Primary Sponsor  
Name  AstraZeneca AB  
Address  151 85 Sodertalje, Sweden 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
AstraZeneca Pharma India Ltd  Block N1, 12th Floor, Manyata Embassy Business Park Rachenahalli, Outer Ring Road, Bangalore – 560045 
 
Countries of Recruitment     Argentina
Australia
Belgium
Brazil
Bulgaria
Canada
Czech Republic
Denmark
France
Germany
Greece
Hong Kong
Hungary
India
Israel
Italy
Japan
Mexico
Netherlands
Peru
Poland
Republic of Korea
Romania
Russian Federation
Singapore
Spain
Sweden
Switzerland
Taiwan
Thailand
Turkey
United Kingdom
United States of America
Viet Nam  
Sites of Study
Modification(s)  
No of Sites = 13  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Suhas Aagre  ACI Cumballa Hill Hospital  Department of Medical Oncology, ACI Cumballa Hill Hospital, 93/95, Kemp’s Corner, August Kranti Maidan, Grant Road, Mumbai – 400036, INDIA
Mumbai
MAHARASHTRA 
9638179656

suhas.aagre@gmail.com 
Dr Sachin Khurana  All India Institute of Medical Sciences, Delhi  Dept. of Medical Oncology, Ansari Nagar, PIN - 110029
New Delhi
DELHI 
9769030180

dr.sachinkhurana@gmail.com 
Dr Viveka B K  Fortis Hospital Ltd  Department of Medical Oncology, 154/9, Bannerghatta Road, Opp to IIM-B, PIN -560076
Bangalore
KARNATAKA 
9945056718

vivekquest@gmail.com 
Dr Shruti Kate  HCG Manavata Cancer Centre  Department of Medical Oncology, HCG Manavata Cancer Centre, Behind Shivang Auto, Mumbai Naka, PIN-422002
Nashik
MAHARASHTRA 
7506117343

drshruti@mcrinasik.com 
Dr Satheesh CT  HealthCare Global Enterprises Ltd   Department of Medical Oncology, HCG Tower, # 8, P. Kalinga Rao Road, Sampangi Ram Nagar, PIN 560027
Bangalore
KARNATAKA 
9242698750

drsatheeshct@gmail.com 
Dr Sewanti Limaye  Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute  Dept. of Medical Oncology, Rao Saheb, Achutrao Patwardhan Marg, Four Bungalows, Andheri West, PIN 400053
Mumbai
MAHARASHTRA 
9619607339

sewanti@yahoo.com 
Dr Gautam Goyal  Max Super Speciality Hospital, Chandigarh  Dept. of Medical Oncology, Phase 6, Sector 56, Chandigarh, PIN 160055
Chandigarh
CHANDIGARH 
8195849111

gautam3636@gmail.com 
Dr Ajay Sharma  Max Super Speciality Hospital, Shalimar Bagh  Dept. of Medical oncology, FC-50, C and D Block, Shalimar Bagh, New Delhi, PIN 110088
New Delhi
DELHI 
9999379838

ajaysharma04@rediffmail.com 
Dr Pragnya Coca   Mazumdar Shaw Medical Center (A unit of Narayana Health)  Department of Medical Oncology, No 258/A, Bommasandra Industrial Area, Anekal Taluk, PIN - 560099
Bangalore
KARNATAKA 
8050004989

pragnya.11@gmail.com 
Dr Ullas Batra  Rajiv Gandhi Cancer Institute & Research Centre  Department of Medical Oncology, Rajiv Gandhi Cancer Institute & Research Centre, D-18, Sector-V, Rohini, PIN-110085
New Delhi
DELHI 
9711080001

ubclinicaltrial@gmail.com 
Dr Shyam Aggarwal   Sir Ganga Ram Hospital  Dept. of Medical Oncology, Old Rajinder Nagar, Rajinder Nagar, New Delhi, PIN 110060
New Delhi
DELHI 
9811075870

drshyam_aggarwal@yahoo.com 
Dr Bivas Biswas  Tata Medical Center, Kolkata  Dept. of Medical Oncology, 14 Major arterial road E-W New Town Rajarhat PIN 700160
Kolkata
WEST BENGAL 
9830922005

bivas.biswas@tmckolkata.com 
Dr CS Pramesh  Tata Memorial Hospital, Mumbai  Dept. of Medical Oncology, Dr. E, Dr Ernest Borges Rd, Parel, Mumbai, PIN 400012
Mumbai
MAHARASHTRA 
9869449070

cspramesh@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 13  
Name of Committee  Approval Status 
Ethics Committee, Sir Ganga Ram Hospital  Approved 
Fortis Hospital Ethics Committee, Bannerghatta Road  Approved 
HCG Central Ethics Committee  Approved 
Institutional Ethics Committee – New Healthcare Nursing Home  Approved 
Institutional Ethics Committee, All India Institue of Medical Sciences, New Delhi  Approved 
Institutional Ethics Committee, Kokilaben  Approved 
Institutional Ethics Committee, Max Super Specialty Hospital, Mohali  Approved 
Institutional Review Board Rajiv Gandhi Cancer Institute and Research Centre  Approved 
Institutional Review Board, Tata Medical Center, Kolkata  Approved 
Manavata Clinical Research Institute Ethics Committee HCG Manavata Cancer Centre  Approved 
Max Healthcare Ethics Committee, Delhi  Approved 
Narayana Health Medical Ethics Committee  Approved 
TMH, Institutional Ethics Committee I and II  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Durvalumab with Platinum based chemotherapy  Durvalumab with Platinum based chemotherapy (paclitaxel PLUS carboplatin (squamous patients only), pemetrexed PLUS carboplatin (non-squamous patients only), or pemetrexed PLUS cisplatin (non-squamous patients only)  
Comparator Agent  Placebo with Platinum based chemotherapy   Placebo with Platinum based chemotherapy (paclitaxel PLUS carboplatin (squamous patients only), pemetrexed PLUS carboplatin (non-squamous patients only), or pemetrexed PLUS cisplatin (non-squamous patients only)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Informed consent
Criteria and procedures initiated with the signing of ICF1
1 ICF1 must be signed and dated prior to any study procedures and prior to the planned surgical resection of the primary NSCLC, with the exception noted below.
i. Exception: Patients will be permitted to sign ICF1 after surgery. In this case, a post surgical whole blood sample and resected tumor tissue must be collected as soon as possible for development of the personalized panel. The plasma sample to determine MRD status must still be collected between Weeks 3 and 4 post-surgery, even if creation of the personalized panel for MRD detection is delayed. Only patients identified as MRD+ based on the post-surgery plasma sample may be randomized in the study, provided all additional inclusion and none of the exclusion criteria are met.
ii. Patients randomized to the MRD- cohort must have had a plasma sample collected prior to surgery and will not be eligible for the study if they signed ICF1 after surgery. Patients will not be excluded from randomization based on the results of the pre-surgical sample.
Age
2 Age ≥18 years at the time of screening.
Sex
3 Male and/or female.
Type of patient and disease characteristics
4. Individuals who have diagnosis of histologically confirmed NSCLC with resectable (stage II-III) disease, Select (ie, T3N2 or T4N2) stage IIIB patients will be eligible, provided that they are upstaged to T3N2 or T4N2 based on confirmed pathology. Patients who are staged as T3N2 or T4N2 prior to surgery are not eligible.
The following criteria must be met prior to surgery or at the time of the surgery:
5 A contrast-enhanced CT/MRI scan of the chest and abdomen (including liver and adrenal glands) must have been done for surgical planning prior to surgery. It is recommended that patients undergo combined FDG-PET (18F-Fluoro-deoxyglucose positron emission tomography) and CT scan in order to rule out detectable extrathoracic, extracranial metastasis and to assess for potential mediastinal lymph node involvement prior to surgery. If only CT is available, or FDG-PET reveals suspicious lymph node mediastinal involvement, it is recommended that invasive pre-operative mediastinal staging is performed according to the algorithm of the European Society of Thoracic Surgeons guidelines (algorithm to follow for primary mediastinal staging if only pre-operative CT is available, algorithm to follow for primary mediastinal staging when PET-CT is available). Brain MRI (preferred) or brain CT with IV contrast is required for complete staging of the tumor. Imaging should occur within 6 weeks prior to surgery.
Complete resection of the primary NSCLC is mandatory. The primary tumor must be deemed resectable by a multidisciplinary evaluation that must include a thoracic surgeon certified or trained according to local standards and who performs lung cancer surgery as a significant part of their practice. Surgical resection of the primary NSCLC can occur by open thoracotomy or by video-assisted thoracic surgery (VATS) and resection can be achieved by segmentectomy, lobectomy, sleeve resection, bilobectomy, or pneumonectomy. Patients undergoing wedge resection are not eligible for this study.
At a minimum, the following parameters should be met for a tumor to be declared completely resected:
(a) The surgeon performing the resection should remove all gross disease by the end of surgery. All surgical margins of resection must be negative for tumor.
(b) Pathology and/or operative reports must include the examination of at least 2 different mediastinal lymph node (N2) levels, one of which is the subcarinal node group (level 7) and the second of which is lobe-specific (defined below).
(c) No extracapsular nodal extension of the tumor is observed in resected mediastinal N2 lymph nodes.
7 Collection of a pre-surgical plasma sample for MRD evaluation is preferred for all patients but is mandatory in order for any MRD- patient to be randomized
The following criteria must be met post-surgery and prior to signing ICF2:
8 Confirmation of suitable resected tumor tissue and whole blood sample for WES of tumor and germline DNA, respectively, and creation of Sponsor-approved personalized panel for MRD determination. Tumor tissue and whole blood samples must be provided to the diagnostic laboratory for development of the personalized panel as soon as possible following pathology confirmation. Germline sequencing of whole blood is mandatory.
9 Established MRD status (+/-) based on Sponsor-approved personalized assay of a plasma sample collected between Weeks 3 and 4 post-surgery.
10 Known tumor PD-L1 status determined at a central reference laboratory testing service using a validated Ventana SP263 PD-L1 immunohistochemistry (IHC) assay prior randomization. Patients with unknown PD-L1 status are not eligible for the study.
11 Post-operative CT scan of the chest and abdomen (including liver and adrenal glands) performed within 28 days prior to randomization. If clinically indicated, additional scans (such as brain MRI [preferred] or brain CT with IV contrast) should be performed to confirm no evidence of metastasis.

Criteria and procedures initiated with the signing of ICF2 (and optional genetic consent)
12 ICF2 must be signed and dated after MRD status is determined; within the 12 weeks (±7 days) following surgery; and prior to initiation of any study-specific procedures, sampling, and analyses per study protocol
13 WHO/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
14 Complete postoperative wound healing must have occurred prior to randomization; patients must have recovered from all acute, reversible toxic effects from prior treatments (excluding alopecia) that could potentially adversely impact further administration of durvalumab/placebo or chemotherapy according to the Investigator’s judgment.
15 Eligible to tolerate 4 cycles of platinum-based adjuvant chemotherapy
16 Adequate organ and marrow function as defined below:
i. Hemoglobin ≥9.0 g/dL
ii. Absolute neutrophil count ≥1.5 × 109/L
iii. Platelet count ≥100 × 109/L
iv. Serum bilirubin ≤1.5 × the upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert’s syndrome, who will be allowed in consultation with their physician.
v. ALT and AST ≤2.5 × ULN
vi. Measured creatinine clearance (CL) ≥40 mL/min or Calculated creatinine CL >40 mL/min as determined by Cockcroft-Gault (using actual body weight)
17 Must have a life expectancy of at least 12 weeks

Weight
18 Body weight >30 kg


 
 
ExclusionCriteria 
Details  Diagnostic assessments
1 Post-operative imaging demonstrating unequivocal evidence of disease recurrence or tissue biopsy-proven disease recurrence. In the event of lymphadenopathy on imaging that would lead to exclusion, histopathological confirmation of lymph node metastasis should be obtained prior to excluding a patient from the study. If pathological confirmation of lymph-node metastasis is not technically feasible and imaging appearance are deemed unequivocal for relapse, the patient will be excluded.
2 EGFR-mutant and/or ALK-translocation as assessed either from the tumor biopsy taken prior to surgery (preferred) or the resected tumor tissue (if biopsy was not evaluable). If a pre surgery biopsy is not available, testing will be conducted as soon as possible post surgery on the resected tumor tissue while the personalized panel is in development; patients will still be allowed to continue with study procedures while testing is ongoing but will be excluded from randomization if their resected tumor tissue tests positive for EGFR mutations and/or ALK translocations. Testing must be performed using a well validated, local regulatory approved test. EGFR/ALK may be tested centrally if local testing is unavailable.
3 Mixed small cell and NSCLC histology.
4 Require re-resection or are deemed to have unresectable NSCLC by a multidisciplinary evaluation that must include a thoracic surgeon who performs lung cancer surgery as a significant part of their practice.
5 Patients who are candidates to undergo only wedge resections.

Medical conditions

6 History of allogeneic organ or bone marrow transplantation.
7 Non-leukocyte-depleted whole blood transfusion within 120 days of genetic sample collection.
8 Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn’s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
i. Patients with vitiligo or alopecia
ii. Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement
iii. Any chronic skin condition that does not require systemic therapy
iv. Patients without active disease in the last 5 years may be included but only after consultation with the Study Physician
v. Patients with celiac disease controlled by diet alone
9 Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active ILD, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent.
10 History of another primary malignancy, except for
i. Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence
ii. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
iii. Adequately treated carcinoma-in-situ without evidence of disease
11 History of active primary immunodeficiency
12 Active infection, including tuberculosis (clinical evaluation that includes clinical history, physical examination, and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (HBV; known positive HBV surface antigen [HBsAg] result), hepatitis C (HCV), or human immunodeficiency virus infection (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
13 Known allergy or hypersensitivity to any of the IPs or any of the IP excipients.
14 Any medical contraindication to treatment with platinum-based doublet chemotherapy as listed in the local labeling.

Prior/concomitant therapy
15 Received any prior adjuvant therapy for NSCLC or any prior exposure to durvalumab.
16 Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy) is acceptable.
17 Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of IP.
18 Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine while receiving IP and up to 30 days after the last dose of IP.
19 Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
20 Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab/placebo. The following are exceptions to this criterion:
i. Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection)
ii. Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
iii. Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)
Prior/concurrent clinical study experience
21 Participation in another clinical study with an IP administered since completion of surgery.
22 Previous IP assignment in the present study.
23 Concurrent enrollment in another clinical study, unless it is an observational (non interventional) clinical study, or during the follow-up period of an interventional study.
24 Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment group assignment.

Other exclusions
25 Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab/placebo.
26 Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.

 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
To assess the efficacy of durvalumab plus SoC chemotherapy compared to placebo plus SoC chemotherapy as measured by DFS in MRD positive patients  To assess the efficacy of durvalumab plus SoC chemotherapy compared to placebo plus SoC chemotherapy as measured by DFS in MRD positive patients - 4.5 years 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
To assess the efficacy of durvalumab plus SoC chemotherapy compared to placebo plus SoC chemotherapy as measured by DFS in all patients  DFS in FAS using Investigator assessments according to RECIST 1.1 - 4.5 years 
To assess the efficacy of durvalumab plus SoC chemotherapy compared to placebo plus SoC chemotherapy as measured by DFS in MRD positive patients and in all patients  DFS using BICR assessments according to RECIST 1.1
in MRD positive analysis set and in FAS - 4.5 years
 
To assess the efficacy of durvalumab plus SoC chemotherapy compared to placebo plus SoC chemotherapy as measured by OS in MRD positive patients and in all patients   OS in MRD positive analysis set and in FAS - 4.5 years 
To assess patient-reported symptoms, functioning, and HRQoL in MRD positive patients treated with durvalumab plus SoC chemotherapy compared to placebo plus SoC chemotherapy   Change from baseline and time to deterioration in EORTC QLQC30 and EORTC QLQ LC13 - 4.5 years 
To assess the PK of durvalumab   Concentration of durvalumab - 4.5 years 
To investigate the immunogenicity of durvalumab  Presence of ADAs for durvalumab - 4.5 years  
Safety objective:
To assess the safety and tolerability profile of durvalumab plus SoC chemotherapy compared to placebo plus SoC chemotherapy in MRD plus patients and in all patients  
AEs physical examinations vital signs and
laboratory findings - 4.5 years
 
Exploratory Objective
o assess the efficacy of durvalumab plus SoC chemotherapy compared to placebo plus SoC chemotherapy on post recurrence outcomes  
PFS using local standard practice - 4.5 years 
To assess the efficacy of durvalumab PLUS SoC chemotherapy to clear ctDNA compared to placebo PLUS chemotherapy in MRD PLUS patients   Correlation of polymorphisms with variation in PK, pharmacodynamics, safety or response observed in patients treated with osimertinib plus chemotherapy- 4.5 Years
 
To assess relationship between treatment effect on DFS and treatment effect on ctDNA endpoints  ctDNA endpoints (as defined above) and DFS - 4.5 years 
To assess prognostic significance of MRD detection as determined by ctDNA in NSCLC  Time from randomization to DFS
in MRD positive vs MRD negative
- 4.5 years 
To assess the association of TMB with efficacy of durvalumab PLUS SoC chemotherapy compared with placebo PLUS SoC chemotherapy   DFS, OS in patients with TMB - 4.5 years 
To investigate the relationship between a patients baseline PD-L1 TC expression and efficacy outcomes with durvalumab PLUS SoC chemotherapy compared with placebo PLUS SoC chemotherapy  IHC analysis of PDL1 TC expression and spatial distribution within the tumor microenvironment relative to efficacy outcomes ie DFS and OS - 4.5 years
 
To investigate the effect of baseline colonic microbiome on response to treatment and the effect of treatment on the microbiome over time  Microbiome profiling and metabolome analysis of stool samples - 4.5 years
 
To investigate biomarkers in tumor and periphery at baseline, on treatment, post-treatment, and or at recurrence wherever feasible to identify markers related to disease, mechanism of action of the drug and or their associations with response and clinical endpoints   Exploratory markers within the peripheral and tumoral compartments.
TMB and somatic mutations in tissue and or blood or plasma.
Changes in RNA DNA or protein will be compared at baseline, on treatment, post-treatment and or at recurrence
Attributes of tumor microenvironment that could be assessed using various methods with spatial resolution such as Mass Spectroscopy or other technologies
- 4.5 years

 
To evaluate patient reported treatment related symptoms using PRO CTCAE
To assess the patient’s global impression of symptoms severity and global treatment tolerability
To explore the impact of treatment and disease on health state utility
To explore the impact of treatment and disease on health care resource use
 
Prespecified items on the PRO CTCAE

Patient global assessments
EQ 5D 5L descriptor and VAS

Health care resource use will be captured, including inpatient admissions ICU admissions and length of stay in the hospital. Study mandated visits are excluded from this assessment
 
 
Target Sample Size   Total Sample Size="332"
Sample Size from India="18" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/09/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/07/2020 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial
Modification(s)  
Years="4"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This is a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-arm study to evaluate the efficacy and safety of durvalumab plus SoC chemotherapy compared to placebo plus SoC chemotherapy in patients with completely resected stage II-III NSCLC who are MRD+ post-surgery.

 

The study will screen approximately 2225 patients and randomize approximately 332 patients with stage II-III NSCLC (select stage IIIB patients with T3N2 or T4N2 disease may be eligible, whose tumors are EGFR and ALK wild type, and who have undergone complete resection.

 

Randomized patients will include approximately 232 MRD+ and 100 MRD- patients. The number of MRD- patients will be capped at 100. There will be a split of approximately 30%/70% of Asian/non-Asian patients within the MRD- randomized population.

 

The study will be conducted in approximately 250 centers globally.

 

The Investigator will decide before randomization which chemotherapy regimen (carboplatin/pemetrexed or cisplatin/pemetrexed) a patient would receive in case the patient is assigned to the osimertinib plus chemotherapy arm.

 

Approximately 332 patients will be randomized 1:1 to treatment with durvalumab for 4 cycles plus SoC chemotherapy for up to 4 cycles or placebo for 4 cycles plus SoC chemotherapy for up to 4 cycles followed by durvalumab or placebo for up to an additional 10 cycles (for a total of 12 months of treatment), until disease recurrence, or until other specific treatment discontinuation criteria are met (whichever occurs first). 
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