| CTRI Number |
CTRI/2024/10/074537 [Registered on: 01/10/2024] Trial Registered Prospectively |
| Last Modified On: |
15/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Clinical trial/study of lung cancer |
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Scientific Title of Study
|
A Phase I-III, Multicenter Study Evaluating The Efficacy And Safety Of Multiple Therapies In Cohorts Of Patients Selected According To Biomarker Status, With locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| BO42777_Version 3_dated 15 Aug 2023 |
Protocol Number |
| NCT05170204 |
ClinicalTrials.gov |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Jyotii Poddaar |
| Designation |
Lead -Clinical Operations |
| Affiliation |
Roche Products (India) Pvt. Ltd. |
| Address |
Roche Products (India) Pvt. Ltd.
146-B, 166 A, Unit No. 7, 8, 9
8th Floor, R City Office, R City Mall
Mumbai
MAHARASHTRA
400086
India |
| Phone |
9136064373 |
| Fax |
|
| Email |
jyotii.poddaar@roche.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Rupesh Choudhary |
| Designation |
Manager -Clinical Operations |
| Affiliation |
Roche Products India Private Limited |
| Address |
Roche Products (India) Pvt. Ltd.
146-B, 166 A, Unit No. 7, 8, 9
8th Floor, R City Office, R City Mall
Mumbai
MAHARASHTRA
400086
India |
| Phone |
9820300215 |
| Fax |
|
| Email |
rupesh.choudhary@roche.com |
|
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Source of Monetary or Material Support
|
| F. HoffmannLa Roche Ltd CH-4070 Basel, Switzerland |
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Primary Sponsor
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| Name |
F HoffmannLa Roche Ltd |
| Address |
Grenzacherstrasse 124, CH-4070 Basel, Switzerland |
| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
|
| Name |
Address |
| Roche Products India Pvt Ltd |
146-B, 166 A, Unit No. 7, 8, 9 8th Floor, R City Office, R City Mall Lal Bahadur Shastri Marg Ghatkopar, Mumbai |
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Countries of Recruitment
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Australia
Belgium
Brazil
Canada
Chile
China
Colombia
Costa Rica
Denmark
France
Germany
Hong Kong
India
Italy
Japan
Netherlands
New Zealand
Norway
Poland
Republic of Korea
Russian Federation
Singapore
Spain
Sweden
Taiwan
Thailand
Turkey
Ukraine
United Kingdom
United States of America |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amit Dutt Dwary |
Apollo Gleneagles Hospitals |
58, Canal Circular Road, Ultadanga 700054
Kolkata
WEST BENGAL |
9007838511
amitdwary@gmail.com |
| Dr Ashok Vaid |
Medanta-The Medicity, Cancer Institute |
Division of Medical, Oncology and Haematology, Sector-38, -122001
Gurgaon
HARYANA |
9810212235
ashok.vaid@medanta.org |
| Dr Ullas Batra |
Rajiv Gandhi Cancer Institute & Research Centre |
D 18, Sector V Rohini-110085
New Delhi
DELHI |
9911080001
ullasbatra@gmail.com |
| Dr Sewanti Limaye |
Sir H. N. Reliance Foundation Hospital and Research Centre |
Prarthana Samaj, Raja Rammohan Roy Rd, Girgaon 400004
Mumbai
MAHARASHTRA |
9619607339
sewanti@yahoo.com |
| Dr Vanita Noronha |
Tata Memorial Hospital |
HBB Block Room no 304, 3rd floor, Department of Medical Oncology Dr Ernest Borges Road Parel 400012
Mumbai
MAHARASHTRA |
9769328047
vanita.noronha@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Institution Review Board |
Submittted/Under Review |
| Institutional Ethics Committee |
Submittted/Under Review |
| Institutional Ethics Committee I/II |
Submittted/Under Review |
| Institutional Ethics Committee of " The Sir H.N. Reliance Foundation Hospital and Research Centre" |
Submittted/Under Review |
| Medanta Institutional Ethics Committee (MIEC) |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung, |
|
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Alectinib |
Participants will receive oral alectinib twice daily with food. |
| Comparator Agent |
Durvalumab |
Participants will receive IV durvalumab every 4 weeks. |
| Intervention |
Entrectinib |
Participants will receive oral entrectinib once daily, with or without food.
|
| Intervention |
Pralsetinib |
Participants will receive oral pralsetinib daily on an empty stomach.
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Body weight 30 kg at screening
Willingness and ability to use the electronic device or application for the electronic patient-reported outcome
Whole-body positron emission tomography computed tomography scan from the base of skull to mid-thighs for the purposes of staging, performed prior and within 42 days of the first dose of cCRT or sCRT
Histologically or cytologically documented locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology
Prior receipt of at least two prior cycles of platinum-based chemotherapy given concurrently with radiotherapy; or at least two prior cycles of platinum-based chemotherapy given prior to radiotherapy
The RT component in the cCRT or sCRT must have been at a total dose of radiation of 60Gy administered by intensity-modulated radiotherapy (preferred) or three dimension conforming technique
No disease progression during or following platinum-based cCRT or sCRT
Life expectancy 12 weeks |
|
| ExclusionCriteria |
| Details |
Any history of previous NSCLC and or any history of prior treatment for NSCLC
Any evidence of Stage IV disease, including, but not limited to, the following pleural effusion, pericardial effusion, brain metastases, history of intracranial hemorrhage or spinal cord hemorrhage, bone metastases, distant metastases
NSCLC known to have a known or likely oncogenic-driver mutation in the EGFR gene, as identified by site local testing or Sponsor central testing
Positive hepatitis B surface antigen test at screening |
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Method of Generating Random Sequence
|
Stratified randomization |
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Method of Concealment
|
Other |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Progression-free survival (PFS) |
From randomization to the first documented disease progression as determined by blinded independent central review (BICR) per Response Evaluation Criterial in Solid Tumors (RECIST) v1.1, or death from any cause, whichever occurs first (up to 3 years) |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Time-to-confirmed deterioration (TTCD) |
From randomization to the first deterioration of 10 points that is either maintained for two consecutive assessments or followed by death from any cause within 3 weeks (up to 3 years) |
| Proportion of participants who have maintained or improved baseline health as measured by the European Organisation for the Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 physical functioning and role functioning scales |
5, 11, and 17 months |
| Proportion of participants who have maintained or improved from their baseline health in cough, chest pain, and dyspnea symptoms as measured using the EORTC QLQ-LC13 |
5, 11, and 17 months |
| Percentage of participants with adverse events (AEs) |
Up to 3 years |
| Overall survival |
From randomization to death from any cause (up to 5 years) |
|
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Target Sample Size
|
Total Sample Size="320"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
03/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
18/10/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="10"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
Not applicable at present |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Study BO42777 is a Phase I-III, global, multicenter, multicohort study to evaluate the efficacy and safety of multiple therapies in patients with locally advanced, unresectable, Stage III NSCLC with eligible biomarker status. This population is based on the Version 8 of the American Joint Committee on Cancer/Union for International Cancer Control NSCLC staging system. Patients with tumors harboring a cohort-eligible biomarker identified through one of the methods specified as follows will be screened for enrollment in the applicable cohort of this study. This platform trial evaluates several investigational medicinal products (IMPs) in biomarker-selected populations; each study treatment is evaluated independently. The cohorts contribute to the overarching hypothesis of the study by evaluating therapies in biomarker-selected, locally advanced, unresectable, Stage III non-small cell lung cancerAn independent data monitoring committee (iDMC) will be used to evaluate interim safety data on a regular basis. |