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CTRI Number  CTRI/2025/12/099413 [Registered on: 18/12/2025] Trial Registered Prospectively
Last Modified On: 12/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Phase 3 Study comparing Trastuzumab Deruxtecan in Combination with Pembrolizumab Versus Platinum-based Chemotherapy in Combination with Pembrolizumab, as First-line Therapy in Participants with Non-Squamous Non-small Cell Lung Cancer 
Scientific Title of Study   A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan in Combination with Pembrolizumab Versus Platinum-based Chemotherapy in Combination with Pembrolizumab, as First-line Therapy in Participants with Locally Advanced Unresectable or Metastatic HER2 overexpressing and PD-L1 TPS 50% Non-squamous Non-small Cell Lung Cancer 
Trial Acronym  DESTINY-Lung06 
Secondary IDs if Any  
Secondary ID  Identifier 
2024-515658-26-00  EudraCT 
DS8201-793 Version 1.0, 02 Dec 2024  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  Shweta Pradhan 
Designation  Head R&D India Operations 
Affiliation  IQVIA RDS (India) Private Limited 
Address  Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli

Bangalore
KARNATAKA
560103
India 
Phone  919833992566  
Fax    
Email  shweta.pradhan@iqvia.com  
 
Details of Contact Person
Public Query  
Name  Shweta Pradhan 
Designation  Head R&D India Operations 
Affiliation  IQVIA RDS (India) Private Limited 
Address  Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli


KARNATAKA
560103
India 
Phone  919833992566  
Fax    
Email  shweta.pradhan@iqvia.com  
 
Source of Monetary or Material Support  
Daiichi Sankyo, Inc 211 Mt. Airy Road Basking Ridge, NJ 07920 United States  
 
Primary Sponsor  
Name  Daiichi Sankyo, Inc 
Address  211 Mt. Airy Road Basking Ridge, NJ 07920 United States  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Belgium
Brazil
Chile
China
France
Germany
Greece
Hong Kong
India
Italy
Japan
Malaysia
Mexico
Poland
Portugal
Republic of Korea
Romania
Spain
Taiwan
Thailand
Turkey
United Kingdom
United States of America  
Sites of Study  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sandip Kumar Barik  All India Institute of Medical Sciences  Sijua, Patrapada, Bhubaneswar-751019,
Khordha
ORISSA 		 9450381454

sandip.barik1@gmail.com 
Dr Chetan Dilip Deshmukh  Deenanath Mangeshkar Hospital & Research Center  Off Karve Road, Erandawane, Pune -411004
Pune
MAHARASHTRA 		 98508 11449

drchetandeshmukh@gmail.com 
DrSwaratika Majumdar  Mazumdar Shaw Medical Center, Narayana Hrudayalaya Limited  No. 258/A, Bommasandra Industrial Area, Anekal Taluk
Bangalore
KARNATAKA 		 8105268637

swaratika.majumdar.dr@narayanahealth.org 
Dr Vivek Agarwala  Narayana Superspeciality Hospital  120/1, Andul Road, Howrah-711103
Kolkata
WEST BENGAL 		 8879222875

drvivekagarwala@gmail.com 
Dr Anshul Rajendraprasad Agarwal  Nirmal Hospital Pvt. Ltd.  Ring Road, Surat-395002
Surat
GUJARAT 		 9969465723

dranshulagarwal@gmail.com 
Dr Vanita Ivan Noronha  Tata Memorial Hospital  Dr. E. Borges Marg, Parel, Mumbai- 400012
Mumbai
MAHARASHTRA 		 9769132804

vanita.noronha@gmail.com 
Dr Tejesh Krishna CH  Yenepoya Medical College Hospital  University Road, Deralakatte, Mangalore-575018
Dakshina Kannada
KARNATAKA 		 9491384521

chtejeshkrishna@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Institutional Ethics committee Deenanath Mangeshkar Hospital And Research Centre  Approved 
INSTITUTIONAL ETHICS COMMITTEE, Faculty Research, AlIMS Bhubaneswar  Submittted/Under Review 
Narayana Health Medical Ethics Committee  Approved 
Nirmal Hospital Ethics Committee  Approved 
NSH Ethics Committee  Submittted/Under Review 
TMH_Institutional Ethics Committee (IEC)- I  Submittted/Under Review 
Yenepoya Ethics Committee 1  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 
Comparator Agent  Carboplatin   Strength: 10 mg/ml concentrate for solution for infusion Route: Intravenous  
Comparator Agent  Cisplatin  Strength: 1mg/ml concentrate for solution for infusion Route: Intravenous  
Comparator Agent  Pembrolizumab   Strength: 100 mg/ 4ml concentrate for solution for infusion Route: Intravenous  
Comparator Agent  Pemetrexed  Strength: 25 mg/ml concentrate for solution for infusion Route: Intravenous  
Intervention  Trastuzumab Deruxtecan  Strength: 100 mg powder for concentrate for solution for infusion Route: Intravenous  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Sign and date the Tissue Screening ICF, prior to any Tissue Screening procedure. Sign and date the Main ICF, prior to the start of any trialspecific qualification procedures.
Sign and date the Optional PGx ICF (included in the Main Screening ICF) prior to any PGx procedure, and the Pregnant Partner ICF, if applicable.
2. Adults 18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is 18 years old.
3. Histologically documented non-squamous locally advanced unresectable or metastatic NSCLC and meets all of the following criteria: Has Stage IV NSCLC disease or Stage IIIB or IIIC disease but is not a candidate for surgical resection or definitive chemoradiation at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition). Has no known AGAs (based on existing test result of local test) that have locally available therapies targeting their AGAs in the first-line advanced/metastatic setting. Has no known HER2 mutation based on existing test results (if approved or validated local test is available). Note: Participants with mixed histology are eligible if adenocarcinoma is the predominant histology. Mixed tumors will be classified based on the predominant cell type.
4. Has not been treated with systemic anticancer therapy for advanced or metastatic non-squamous NSCLC. Participants who received adjuvant or neoadjuvant therapy other than those listed below, including ICI (ie, anti-PD-1/PD-L1) or a platinum-based regimen, are eligible if the last dose of adjuvant/neoadjuvant therapy was given at least 6 months before the date of the first trial dose and should not have progressed on or within 6 months of the last dose date of adjuvant/neoadjuvant therapy. a. Any agent, including an ADC, containing a chemotherapeutic agent targeting topoisomerase I. b. HER2-targeted antibody-based anticancer therapy.
5. Has adequate tumor tissue sample (not previously irradiated) available for assessment of HER2 and PD-L1 expression by central or Sponsor specified laboratory. A new biopsy is required if the participant’s most recent archival tumor tissue sample cannot be supplied. Details pertaining to tumor tissue submission can be found in the Trial Laboratory Manual.

 
 
ExclusionCriteria 
Details  1. Has a medical history of MI within 6 months before randomization/enrollment or
symptomatic CHF (NYHA Class II to Class IV). Participants with troponin levels above
the ULN at Screening (as defined by the manufacturer) and without any MI-related
symptoms should have a cardiologic consultation during the Screening Period to rule out MI.
2. Has a QTc prolongation to 480 ms based on the average of the Screening triplicate 12- lead ECG.
3. Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
4. Has lung-specific, intercurrent, clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the trial randomization, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc.).
5. Had a prior complete pneumonectomy.

 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Progression Free Survival by Blinded Independent Central Review  Radiographic disease assessments will be performed at baseline, then every 6 weeks (±7 days) for the first 54 weeks, and every 9 weeks (±7 days) thereafter until documented radiological progression, death, or study discontinuation 
 
Secondary Outcome  
Outcome  TimePoints 
Overall Survival  From date of randomization to the date of death due to any cause, up to 85 months. 
 
Target Sample Size   Total Sample Size="686"
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" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   07/04/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/09/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="6"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

This clinical trial is designed to assess the efficacy and safety of trastuzumab deruxtecan (T-DXd; Enhertu®) in combination with pembrolizumab versus platinum-based chemotherapy in combination with pembrolizumab in participants with no prior therapy for locally advanced unresectable or metastatic non-squamous NSCLC, whose tumors have HER2-overexpressing and PD-L1 TPS <50% without known AGA that have locally available therapies targeting their AGAs in first-line advanced/metastatic setting.

 
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