CTRI/2024/10/075244 [Registered on: 14/10/2024] Trial Registered Prospectively
Last Modified On:
05/03/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug Biological
Study Design
Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study
Randomized, multicenter, double-blind, Phase 3 study investigating the safety and efficacy of dostarlimab plus belrestotug compared with pembrolizumab plus
placebo in participants with previously untreated, unresectable, locally advanced
or metastatic Non-small-cell lung cancer
Scientific Title of Study
A randomized, multicenter, double-blind, Phase 3 study to investigate the safety and efficacy of belrestotug in combination with dostarlimab compared with placebo in combination with pembrolizumab in participants with previously untreated, unresectable, locally advanced or metastatic PD-L1 selected non small cell lung cancer (GALAXIES LUNG 301)
Trial Acronym
GALAXIES LUNG 301
Secondary IDs if Any
Secondary ID
Identifier
213823 Version Final Protocol Dated 09 JAN 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Yogesh Mane
Designation
Therapy Area Lead
Affiliation
GSK Pharma India Private Limited
Address
GSK Pharma India Private Limited C/O GlaxoSmithKline Pharmaceuticals Limited Dr. Annie Besant Road, Worli, Mumbai
Mumbai MAHARASHTRA 400030 India
Phone
8452888978
Fax
Email
yogesh.x.mane@gsk.com
Details of Contact Person Scientific Query
Name
Dr Yogesh Mane
Designation
Therapy Area Lead
Affiliation
GSK Pharma India Private Limited
Address
GSK Pharma India Private Limited C/O GlaxoSmithKline Pharmaceuticals Limited Dr. Annie Besant Road, Worli, Mumbai
MAHARASHTRA 400030 India
Phone
8452888978
Fax
Email
yogesh.x.mane@gsk.com
Details of Contact Person Public Query
Name
Swapnali Raut
Designation
Director, Clinical Operations India
Affiliation
GSK Pharma India Private Limited
Address
GSK Pharma India Private Limited C/O GlaxoSmithKline Pharmaceuticals Limited Dr. Annie Besant Road, Worli, Mumbai
Mumbai MAHARASHTRA 400030 India
Phone
9821415224
Fax
Email
swapnali.a.raut@gsk.com
Source of Monetary or Material Support
GSK Pharma India Private Limited C/O GlaxoSmithKline Pharmaceuticals Limited Dr. Annie Besant Road, Worli, Mumbai, - 400030, India.
Primary Sponsor
Name
GlaxoSmithKline
Address
GSK Research & Development Limited 980 Great West Road, Brentford TW8 9GS, United Kingdom
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
Argentina Belgium Brazil Bulgaria Canada China Czech Republic Finland France Germany Greece Hong Kong Hungary India Japan Panama Philippines Portugal Singapore Taiwan Thailand Estonia Italy Mexico Netherlands Poland Romania Serbia Slovakia Slovenia Spain Sweden Turkey United Kingdom United States of America Republic of Korea
Clinical Research Room
Dept. of Radiation Oncology
AIIMS, Sijua, Patrapada, Bhubaneswar
Odisha-751019, India
9438884060
drdkparida@gmail.com
Dr Shailesh Bondarde
Apex Wellness Hospital
Oncology department Basement Floor/Bunker area Apex Wellness hospital ,
Survey no.799, Plot No.187,
Behind Prakash Petrol Pump,
Govind Nagar, Nashik 422009 , Maharashtra, India
Nashik MAHARASHTRA
9822012427
shaileshbondarde1971@gmail.com
Dr Priya Tiwari
Artemis Cancer Institute
4th floor HR Building Department Clinical Research, Artemis Hospital, Sector-51, Gurugram 122001, Haryana-India
North DELHI
8377828241
priya.tiwari@artemishospitals.com
Dr Gopal Raja
Government Royapettah Hospital
Floor No: 3, Room No: C 302, Medical Oncology Department, Cancer Block, No: 1, West Cott Road, Royapettah, Chennai 600014, Tamil Nadu, India. Chennai TAMIL NADU
9841107677
grajaro78@gmail.com
Dr Suprana Kanti Pal
Institute of Post Graduate Medical Education and Research
IPGME&R and SSKM Hospital Department of Radiotherapy, Chest and Cancer Block, Ground Floor, Room no. 12
Address: 244 AJC Bose Road Kolkata West Bengal- 700020, India
Kolkata WEST BENGAL
8584952141
suparna.k.pal@gmail.com
Dr Rohan Bhise
KLE Society s Dr Prabhakar Kore Hospital and Medical Research Centre
Site Management Office, Second Floor Sarawati Ward KLES Dr Prabhakar Kore Hospital and MRC, Nehru Nagar, Belgaum-590010, Karnataka India Belgaum KARNATAKA
9448866712
rohanbhise30@gmail.com
Dr Nilesh Dhamne
Kolhapur Cancer Centre Private Limited
Clinical Research Department, Room no. 73, 3rd floor, Kolhapur Cancer Centre Private Limited A/P. R. S. No. 238, Opp. Mayur Petrol Pump, Gokul Shirgoan, Maharashtra 41623 India Kolhapur MAHARASHTRA
7738245698
dr.nilesh.gmc@gmail.com
Dr Lokesh K N
Radhakrishna Multispeciality Hospital and IVF Center
4th floor, Consultation Room, Clinical Research Department, 3/4 Sunrise Tower, J P Road, Girinagar, opp. Canara Bank, Bangalore-560085, Karnataka, India Bangalore KARNATAKA
8971609070
drlokeshkn.rmh@gmail.com
Dr Ghanashyam Biswas
Sparsh Hospital & Critical Care Pvt Ltd
Department Clinical Research
Annexure Building, Ground Floor,
Room No 1,
Sparsh Hospitals & Critical Care (P) Ltd. A/407, Saheed Nagar, Bhubaneswar, Odisha, 751007, India
9937500878
drgbiswas@gmail.com
Dr Kumar Prabhash
Tata Memorial Hospital
3rd floor main building 372, 373 Department Clinical Research Secretariat, Tata Memorial Hospital, Dr. E. Borges Road, Parel 400012, Mumbai, India Mumbai MAHARASHTRA
9167760576
kprabhash1@gmail.com
Dr Apurva Patel
The Gujarat Cancer and Research Institute
Clinical Trail Wing, C-112, 1st Floor, The Gujarat Cancer & Research Institute,
M. P. Shah Cancer Hospital,
Civil Hospital Campus, Asarwa,
Ahmedabad - 380016 Gujarat , India.
Ahmadabad GUJARAT
9825940769
apurva.patel@gcriindia.org
Dr Sunil Gupta
Venkateshwar Hospital
ROOM No. 2112 FLOOR NO. Second floor, Old Building, Department of Haemato-Medical Oncology & BMT
HOSPITAL ADDRESS: Venkateshwar Hospital Sector 18A Dwarka New Delhi-110075, India
New Delhi DELHI
9811102971
drsgonco@rediffmail.com
Dr Shashidhar Karpurmath
Vydehi Institute of Medical Sciences and Research Centre
Ground Floor, OPD Building, Examination room no 1, Medical oncology Department, Vydehi Institute Of Medical Sciences & Research centre, # 82 EPIP Area, Nallurahalli, Whitefield Bangalore- 560066, Karnataka, India
Bangalore KARNATAKA
Apex Wellness Ethics Committee Apex Wellness Hospital Survey no 799 Plot No l87 Behind Prakash Petrol Pump Govind Nagar Nashik Maharashtra 422009 India
Approved
Artemis Health Sciences Institutional Ethics Committee 2nd Floor B wing (ICU) Artemis Hospitals Sector 51 Gurgaon Haryana 122001 India
Approved
GCRI/GCS Ethics Committee The Gujarat Cancer and Research Institute M P Shah Cancer Hospital New Civil Hospital Campus Asarwa Ahmedabad 380016 Gujarat India
Approved
IEC Venkateshwar Hospital Unit of ASHA Sector 18 A Dwarka New Delhi110075 India
Approved
Institute of Ethics Committee BGS Global Institute of Medical Sciences No. 67 BGS Healtrh and Education City, Uttarahalli Road, Kengeri, Bangalore 560060 Karnataka
Approved
Institutional Ethics Committee All India Institute of Medical Sciences Sijua Patrapada Bhubaneshwar Orissa 751019 India
Approved
Institutional Ethics Committee GKMC Govt Kilpauk Medical College and Hospital Chennai Tamil Nadu 600010 India
Approved
Institutional Ethics Committee I & II Institutional Ethics Committee 3rd Floor Main Building Tata Memorial Hospital Dr Ernest Borges Parel Mumbai 400012 India
Institutional Ethics Committee, KLE University KLE University KLE Dr. P K Hospital and MRC Nehru Nagar Belagavi Belagavi Belagavi (Belgaum) Karnataka - 590010 India
Approved
IPGME & R Research Oversight Committee IPGME & R and SSKM Hospital 244 AJC Bose Road Bhowanipore Kolkata West Bengal 700020 India
Approved
KCC Institutional Ethics Committee Kolhapur Cancer Centre Pvt.Ltd. R.S.238.Opp Mayur Petrol Pump Gokul Shirgaon, Kolhapur Kolhapur Kolhapur Maharashtra - 416234 India
Approved
Vyedhi Institutional Ethics Committee Vydehi Institute of Medical Sciences & Research Centre 82 E P I P Area Whitefield Bangalore Karnataka 560066 India
(1) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Dostarlimab plus Belrestotug
1) Dostarlimab (500 mg Q3W) plus Belrestotug (400 mg Q3W)
2) Frequency- once every 3 weeks
3) Route of Administration- IV infusion
4) Total Duration- will be until disease progression, clinical deterioration,
unacceptable toxicity, death, or withdrawal.
Comparator Agent
Pembrolizumab (Q3W) plus Placebo (Q3W)
1) Pembrolizumab (200 mg Q3W) plus Placebo (Q3W)
2) Frequency- Once every 3 week
3) Route of Administration- IV infusion
4) Total Duration- will be until disease progression, clinical deterioration,
unacceptable toxicity, death, or withdrawal.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
95.00 Year(s)
Gender
Both
Details
1)Participants are eligible to be included in the study only if all of the following criteria apply
2)Is capable of giving signed informed consent having age atleast 18 or the legal age of consent in the jurisdiction in which the study is taking place
3)ALocally advanced, unresectable NSCLC (not eligible for curative surgery and/or definitive radiotherapy with or without chemotherapy), or Metastatic NSCLC.
4)Has not received prior systemic therapy.
5)Has a PD-L1-high (TC 50%) tumor as determined by the VENTANA PD-L1(SP263) CDx Assay at a central laboratory.
6)Has an ECOG PS score of 0 or 1 and adequate organ function.
7)If of childbearing potential, female participants must be willing to use contraception.
8)Contraceptive use by female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding.
ExclusionCriteria
Details
Participants are excluded from the study if any of the following criteria apply-
1. Has NSCLC with a tumor that harbors any of the following molecular alterations:
a. EGFR mutations that are sensitive to available targeted inhibitor therapy (including, but not limited to, deletions in exon 19, exon 20 insertion mutation, and exon 21 [L858R] substitution mutation). All participants with nonsquamous histology must have been tested for EGFR mutation status using a tissue-based test; use of an approved test is strongly encouraged. Participants with squamous histology do not need to be tested for EGFR mutation status. Participants with nonsquamous histology and unknown or indeterminate EGFR status are excluded.
b. ALK translocations that are sensitive to available targeted inhibitor therapy. All participants with nonsquamous histology must have been tested for ALK fusion mutation status using a tissue-based test; use of an approved test is strongly encouraged. Participants with squamous histology do not need to be tested for ALK fusion mutation status. Participants with nonsquamous histology and unknown or indeterminate ALK status are excluded.
c. Any other known genomic aberrations or oncogenic driver mutations for which a locally approved targeted therapy is available for first-line treatment of locally advanced or metastatic NSCLC.
2) Has had surgery within 4 weeks of the first dose of study intervention and has not
recovered from AEs (i.e., has any ongoing surgery-related events equal to or more than than grade 1)
3) Has received prior therapy with any immune-checkpoint inhibitors, including antibodies or drugs targeting PD-(L)1, CTLA-4, TIGIT, or other checkpoint pathways
4) Has never smoked, defined as smoking less than 100 tobacco cigarettes in a lifetime
5) Has an invasive malignancy or history of invasive malignancy other than the disease under study within the last 5 years,except as noted below:
a. Participants may be enrolled in the study with a history of any other invasive malignancy for which the participant was definitively treated, from which the
participant has been disease-free for at least 2 years, and which, in the opinion of the principal investigator and medical monitor, is not expected to affect the evaluation of the effects of the study intervention on the currently targeted malignancy.
b. Participants with curatively treated basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, and/or in situ breast cancer may be enrolled in the study.
6) Has either of the following:
a. Known symptomatic, untreated, or actively progressing brain metastases.
b. Any leptomeningeal disease (regardless of symptomatology, treatment status, or stability).
7) Has autoimmune disease or syndrome (current or history thereof) that required systemic treatment within the past 2 years. Replacement therapies (e.g., insulin, thyroxine, or physiologic doses of corticosteroids for treatment of adrenal or pituitary
insufficiency) are not considered systemic treatments and are allowed.
8) Has received systemic steroid therapy within 3 days prior to the first dose of study intervention or is receiving any other form of immunosuppressive medication. Replacement therapy is not considered a form of systemic therapy.
a. Corticosteroid use is allowed as premedication for hypersensitivity reactions (e.g., IV contrast allergies/reactions).
b. Use of topical, inhaled, or intranasal corticosteroids, local steroid injection, or steroid eye drops is allowed.
c. Participants who receive daily steroid replacement therapy are an exception to
this criterion. Daily prednisone at doses of ≤10 mg is an example of replacement
therapy and are permitted in this study. Equivalent hydrocortisone doses are also
permitted if administered as a replacement therapy.
9) Has received any live vaccine within 30 days prior to first dose of study intervention.
10) Has any history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis.
11) Has advanced, symptomatic, or visceral spread and is considered to be at imminent risk of life-threatening complications (including, but not limited to, participants with massive uncontrolled effusions [e.g., pleural, pericardial, peritoneal]).
12) Has symptomatic ascites, pleural effusion, or pericardial effusion. A participant who is clinically stable following treatment of these conditions (including therapeutic thoracocentesis, paracentesis, or pericardiocentesis) is eligible if the participant
otherwise meets entry criteria.
13) Has active inflammatory bowel disease, acute diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, or peritoneal carcinomatosis.
14) Has a history or evidence of cardiac abnormalities within the 6 months prior to
enrollment, including:
a. Serious, uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities including second-degree (Type II) or third-degree AV block.
b. Cardiomyopathy, myocarditis, myocardial infarction, acute coronary syndromes (including angina pectoris), coronary angioplasty, stenting, or bypass grafting.
c. Congestive heart failure (Class III or IV) as defined by the New York Heart Association functional classification system
d. Symptomatic pericarditis.
15) Has current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
16) Has any infectious diseases described below:
a. A severe infection requiring IV antibiotics or requiring hospitalization for infection or complication of infection or severe pneumonia within 4 weeks prior
to randomization.
b. Active tuberculosis (i.e., history of exposure or history of positive tuberculosis test, plus presence of clinical symptoms or physical or radiographic findings).
c. Has a known HIV infection
17) Has a history of severe hypersensitivity to mAbs or to any of the excipients in the formulations of the components of the study interventions.
18) Has any serious and/or unstable pre-existing medical (aside from malignancy), psychiatric, or other condition that could, in the opinion of the investigator, interfere with the participant’s safety, obtaining informed consent, or compliance with the study procedures.
19) Is, at the time of signing the ICF, a regular user (including recreational use) of any illicit drugs or has a recent history (within the last year) of substance abuse (including alcohol) that, in the opinion of the investigator, would interfere with the evaluation of the study intervention or interpretation of safety.
20) Is currently participating in or has participated in a study of an investigational therapy within 4 weeks prior to the first dose of study intervention.
21) Has a history of allogeneic tissue/stem cell transplant or solid organ transplant
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Alternation
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Progression-free survival per RECIST 1.1 by Blinded independent central review
Overall survival
Time point - defined as the time from the date of randomization to the date of first documented Progressive disease or death
due to any cause, whichever comes first
Secondary Outcome
Outcome
TimePoints
To Evaluate Efficacy-
Objective response rate - defined as the percentage of participants with a confirmed Complete response or confirmed Partial Response per RECIST 1.1 by investigator assessment
End of study
To Evaluate Efficacy-
• Molecular response rate, defined as the percentage of participants with a molecular response
• Progression-free survival per RECIST 1.1 by investigator assessment,
The time from the date of randomization to the date of first
documented Progressive disease or death due to any cause, whichever comes first
To Evaluate Efficacy-
Duration of response per RECIST 1.1 by investigator assessment,
Time from the date of first confirmed response (Complete Response or Partial Response) to the date of first documented Progressive Disease or death due to any cause, whichever comes first
To Evaluate Efficacy-
Time to first subsequent therapy
Time from the date of randomization to the date of the first subsequent anticancer therapy or death,
whichever occurs first
To Evaluate Safety
• Incidence of Treatment-emergent adverse events, Serious Adverse Events, & Adverse Events of Special Interest
• Incidence of Treatment-emergent adverse events/Serious Adverse Events leading to dose modifications or treatment discontinuations
From administration of first dose to end of study or consent withdrawal which ever comes first.
Target Sample Size
Total Sample Size="1000" Sample Size from India="36" 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)
16/12/2024
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
02/07/2024
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="7" Months="4" Days="0"
Recruitment Status of Trial (Global)
Open to Recruitment
Recruitment Status of Trial (India)
Open to Recruitment
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Purpose
The purpose of this Phase 3 study is to evaluate the efficacy, safety, PK, and pharmacodynamics of dostarlimab plus belrestotug compared with pembrolizumab plus placebo in participants with previously untreated, unresectable, locally advanced or metastatic PD-L1-high NSCLC.
Hypothesis
This Phase 3 study design is based on the hypothesis that a combination of the anti-PD-1 mAb dostarlimab with the anti-TIGIT mAb belrestotug compared with standard of care (pembrolizumab) will lead to a meaningful improvement in PFS and OS for participants with previously untreated, unresectable, locally advanced or metastatic NSCLC with a high PD-L1 expression (TC ≥50%).