CTRI/2025/11/097084 [Registered on: 07/11/2025] Trial Registered Prospectively
Last Modified On:
03/11/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study
A trial to learn how safe datopotamab deruxtecan (Dato-DXd) is compared to docetaxel and how well Dato-DXd works in adults with advanced or metastatic TROP2-positive, non-squamous non-small cell lung cancer (NS-NSCLC)
Scientific Title of Study
A Phase III, Randomised, Open-Label, Multicentre Study of Datopotamab Deruxtecan or Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous Non Small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung17)
Trial Acronym
TROPION-Lung17
Secondary IDs if Any
Secondary ID
Identifier
D763QC00001 Version Number: 1.0 Version Date: 26 Feb 2025
Protocol Number
NCT06676917
ClinicalTrials.gov
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Mr Sandeep AV
Designation
Senior Director, Oncology Country Head, Site Management & Monitoring India
Affiliation
AstraZeneca Pharma India Ltd
Address
Block N1, 12th Floor, Manyata Embassy Business Park
Rachenahalli, Outer Ring Road, Bangalore – 560045, India
Bangalore KARNATAKA 560045 India
Phone
9845079472
Fax
080-67748857
Email
sandeep.av@astrazeneca.com
Details of Contact Person Scientific Query
Name
Mr Sandeep AV
Designation
Senior Director, Oncology Country Head, Site Management & Monitoring India
Affiliation
AstraZeneca Pharma India Ltd
Address
Block N1, 12th Floor, Manyata Embassy Business Park
Rachenahalli, Outer Ring Road, Bangalore – 560045, India
Bangalore KARNATAKA 560045 India
Phone
9845079472
Fax
080-67748857
Email
sandeep.av@astrazeneca.com
Details of Contact Person Public Query
Name
Mr Sandeep AV
Designation
Senior Director, Oncology Country Head, Site Management & Monitoring India
Affiliation
AstraZeneca Pharma India Ltd
Address
Block N1, 12th Floor, Manyata Embassy Business Park
Rachenahalli, Outer Ring Road, Bangalore – 560045, India
Bangalore KARNATAKA 560045 India
Phone
9845079472
Fax
080-67748857
Email
sandeep.av@astrazeneca.com
Source of Monetary or Material Support
AstraZeneca AB
151 85 Sodertalje, Sweden
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, India
Countries of Recruitment
Australia Austria Belgium Belize Canada China France Germany Hungary India Italy Japan Poland Republic of Korea Spain Taiwan Thailand Turkey United Kingdom United States of America Viet Nam
Sites of Study
No of Sites = 5
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Sachin Khurrana
All India Institute of Medical Sciences
Department of Medical Oncology
All India Institute of Medical Sciences (AIIMS)
Dr B.R. Ambedkar Institute Rotary Cancer Hospital
Ansari Nagar, New Delhi 110029, India
New Delhi DELHI
9769030180
dr.sachinkhurana@gmail.com
Dr Mukesh Chaudhari
HCG Manavata Cancer Centre
Department of Medical Oncology
Manavata Health Campus, Mumbai Naka, Nashik 422002, Maharashtra, India
Nashik MAHARASHTRA
9096920416
drmukesh@mcrinasik.com
Dr Satheesh C T
Health Care Global Enterprises Limited
Department of Medical Oncology
No 8, HCG Towers, P. Kalinga Rao Road, Sampangi Ram Nagar, Bangalore, Karnataka 560027, India
Bangalore KARNATAKA
9242698750
drsatheesh.ct@hcgel.com
Dr Rajiv Lochan Jena
Netaji Subhash Chandra Bose Cancer Research Institute
Department of Medical Oncology
3081, Nayabad, New Garia, Kolkata-700094; West Bengal, India
Kolkata WEST BENGAL
8617775659
rajivjena1986@gmail.com
Dr Nandini Menon
Tata Memorial Centre
Department of Medical Oncology
E Borges Marg, Parel, Mumbai-400012, Maharashtra, India
Mumbai MAHARASHTRA
9769178270
nandini.menon1412@gmail.com
Details of Ethics Committee
No of Ethics Committees= 5
Name of Committee
Approval Status
Ethics Committee N S C B C Research Institute Netaji Subhash Chandra Bose Cancer Hospital
Approved
HCG Central Ethics Committee HCG-Bangalore
Approved
Institute Ethics Committee All India Institute of Medical Sciences
Submittted/Under Review
Institutional Ethics Committee-I & II Tata Memorial Centre,
Submittted/Under Review
Manavata Clinical Research Institute Ethics Committee, HCG Manavata Cancer Centre,
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: C390||Malignant neoplasm of upper respiratory tract, part unspecified,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Comparator Arm
Docetaxel
75 mg/m2 Q3W IV Infusion, Day 1 of each 21-day cycle
Intervention
Experimental Arm
Volrustomig
Datopotamab-Deruxtecan 6 mg/kg (up to a maximum of 540 mg for patients Greater than or equal 90 kg) Q3W
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
Inclusion criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
1 Participant must be Greater than or equal 18 years old (or the legal age of consent per local regulatory requirements), at the time of signing the ICF.
2 Has pathologically documented Stage IIIB, IIIC, or Stage IV non-squamous NSCLC without AGA at the time of randomisation (based on the American Joint Committee on Cancer, 9th Edition) and meets the following criteria for NSCLC:
a_ Participants must have documented negative test results for EGFR (eg, exon 19 deletion or exon 21 L858R, exon 21 L861Q, exon 18 G719X, or exon 20 S768I mutation), ALK, and ROS1 genomic alterations.
Note: If test results for EGFR, ALK, and ROS1 are not available, participants are required to undergo prospective testing performed centrally for these genomic alterations in a Sponsor-designated central laboratory.
b_ Has no known tumour genomic alterations in NTRK, BRAF, RET, MET exon 14 skipping, KRAS G12C, HER2 or any other actionable driver oncogenes for which there are locally approved and available targeted first-line therapies.
c_ Note: Participants whose tumours harbour KRAS (exception G12C) mutations are eligible for the study.
d_ Prospectively assessed TROP2 QCS-NMR positive based on results from an appropriately validated investigational TROP2 RxDx device in a Sponsor-designated, regulatory compliant central laboratory.
e_ Note: See Appendix K for scenarios based on diagnostic stage and treatment history at study entry.
3 Participants must have documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC.
4 Participants must have received PBC in combination with anti PD 1/anti-PD-L1 mAb as the only prior line of therapy or received PBC and anti-PD-1/anti-PD-L1 monoclonal antibody (in either order) sequentially as the only 2 prior lines of therapy. This will include participants initially diagnosed with:
(a) Metastatic NSCLC who have received:
PBC in combination with anti-PD-1/anti-PD-L1 mAb as the only prior line of systemic therapy.
OR
Received PBC and anti-PD-1/anti-PD-L1 mAbs sequentially (in either order) as the only 2 prior lines of therapy.
(b) Locally advanced disease who received PBC with or without radiotherapy, followed by maintenance anti PD 1/anti-PD-L1 mAbs and progressed within 12 months after completion of PBC or who has subsequently received anti PD 1/anti PD-L1 mAb therapy (with or without platinum) for recurrent disease.
(c) Participants initially presenting with resectable disease who received neoadjuvant and/or adjuvant PBC and anti-PD-1/anti-PD-L1 mAbs concurrently and progressed within 12 months after completion PBC or who has subsequently received anti PD 1/anti-PD-L1 mAb therapy (with or without platinum) for recurrent disease.
Note:
Participants who received anti-PD-1/anti-PD-L1 mAbs as first-line therapy may have received the combination of PBC and anti-PD-1/anti-PD-L1 mAbs in the second line.
Anti-PD-1/anti-PD-L1 mAbs includes bispecific antibodies or multitargeting proteins that are directed against PD-1 or PD-L1 as one of their targets.
5 Must provide an acceptable FFPE tumour sample for assessment of TROP2. The sample must be newly acquired tumour biopsy from the current disease setting (preferred) or an archival tumour sample taken less than 24 months prior to signing the ICF. If the archival tumour sample is more than 24 months old and a new tumour biopsy cannot be obtained, the use of such a sample must be discussed with the Study Clinical Lead on a case-by-case basis.
6 The FFPE sample must meet the requirements specified in the Laboratory Manual or Pathology Manual and summarised in Section 8.8.
7 At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL at baseline and can be accurately measured at baseline as Greater than or equal 10 mm in the longest diameter (except lymph nodes, which must have short axis Greater than or equal 15 mm) with CT or MRI and is suitable for accurate repeated measurements (see Appendix F). If only one measurable lesion exists, it is acceptable to be used (as a TL) as long as it has not been previously irradiated. Lesions biopsied during the screening period are only accepted as measurable lesions if they are the only lesion available and in that case the baseline scan must be performed at least 2 weeks after the biopsy.
8 ECOG PS of 0 or 1, with no deterioration over the previous 2 weeks prior to screening.
9 Has life expectancy Greater than or equal 3 months based on Investigator’s opinion.
10 Adequate bone marrow reserve and organ function within 7 days before randomisation
11 Has LVEF Greater than or equal 50percent by either ECHO or MUGA scan within 28 days before randomisation.
12 Has adequate blood clotting function defined as INR/prothrombin time and either partial thromboplastin or aPTT Less than or equal 1.5 × ULN.
13 Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
14 Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this CSP.
Other Inclusion Criteria
15 All races, gender and ethnic groups are eligible for this study.
ExclusionCriteria
Details
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
1 Squamous, mixed NSCLC, or SCLC histology.
2 NSCLC disease that is eligible for definitive local therapy alone.
3 As judged by the Investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, including active bleeding diseases and significant cardiac or psychological conditions), history of allogenic organ transplant, and/or substance abuse which, in the Investigator’s opinion, makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocol.
4 History of another primary malignancy other than NSCLC, except for malignancy treated with curative intent with no known active disease within 3 years before randomisation and of low potential risk for recurrence. Exceptions include adequately resected non melanoma skin cancer (basal cell carcinoma of the skin or squamous cell carcinoma of the skin) and curatively treated in situ disease.
5 Persistent toxicities caused by previous anti-cancer therapy, excluding alopecia, not yet improved to Grade Less than or equal 1 or baseline. Note: participants may be enrolled with some chronic, stable Grade 2 toxicities (defined as no worsening to Greater than Grade 2 for at least 3 months prior to randomisation and managed with SoC treatment) which the Investigator deems related to previous anti-cancer therapy, including (but not limited to):
(a) Chemotherapy-induced neuropathy.
(b) Fatigue.
(c) Residual toxicities from prior immunotherapy treatment: Grade 1 or Grade 2 endocrinopathies, which may include but are not limited to hypothyroidism/hyperthyroidism, Type I diabetes, hyperglycaemia, adrenal insufficiency, or adrenalitis; and skin hypopigmentation (vitiligo).
Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention in the opinion of the Investigator may be included (eg, hearing loss).
6 Spinal cord compression or brain metastases, unless asymptomatic, stable, and not requiring treatment with corticosteroids or anticonvulsants for at least 7 days prior to randomisation. Participants with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure). A minimum of 2 weeks must have elapsed between the end of brain radiotherapy and randomisation. Note: A CT or MRI scan of the brain at baseline is required for all participants. For those participants in whom central nervous system metastases are first discovered at the time of screening, the treating Investigator should consider delay of study treatment to document stability of central nervous system metastases with repeat imaging at least 4 weeks later (in which case, repeat of all screening activity may be required).
7 Leptomeningeal carcinomatosis or metastasis.
8 Has significant third-space fluid retention (for example ascites or pleural effusion) and is not amenable for required repeated drainage.
9 Clinically significant corneal disease.
10 Has active or uncontrolled hepatitis B or C virus infection. Participants are eligible if they:
a. Have been curatively treated for HCV infection as demonstrated clinically and by viral serologies.
b. Have received HBV vaccination with only anti-HBs positivity and no clinical signs of hepatitis
c. Are HBsAg- and anti-HBcplus (ie, those who have cleared HBV after infection) and meet conditions i-iii of criterion “d” below:
d. Are HBsAgplus with chronic HBV infection (lasting 6 months or longer) and meet conditions i-iii below:
HBV DNA viral load Less than 2000 IU/mL.
Have normal transaminase values, or, if liver metastases are present, abnormal transaminases, with a result of AST/ALT Less than 3 ULN, which are not attributable to HBV infection.
Start or maintain antiviral treatment if clinically indicated as per the Investigator.
11 Known HIV infection that is not well controlled. All of the following criteria are required to define an HIV infection that is well controlled: undetectable viral RNA, CD4plus count Greater than or equal 350, no history of AIDS defining opportunistic infection within the past 12 months, and stable for at least 4 weeks on the same anti-HIV medications (meaning there are no expected further changes in that time to the number or type of antiretroviral drugs in the regimen). If an HIV infection meets the above criteria, monitoring of viral RNA load and CD4plus count is recommended. Participants must be tested for HIV during the screening period if acceptable by local regulations or an IRB/IEC.
12 Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals; suspected infections (eg, prodromal symptoms); or inability to rule out infections (participants with localised fungal infections of skin or nails are eligible).
13 Known to have active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).
14 Resting ECG with clinically abnormal findings per Investigator discretion.
15 Uncontrolled or significant cardiac disease including:
a. Myocardial infarction or uncontrolled/unstable angina within 6 months before randomisation.
b. Congestive heart failure (New York Heart Association Class II to IV).
c. Uncontrolled hypertension (resting systolic blood pressure Greater than 180 mmHg or diastolic blood pressure Greater than 110 mmHg).
d. Cardiac arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication or arrhythmias controlled by
pacemakers may be permitted based on the Investigator judgement with cardiologist consultation recommended.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To assess the superiority of Dato-DXd vs docetaxel by assessment of PFS by BICR in participants with TROP2 QCS-NMR positive non-squamous NSCLC without AGA
To assess the superiority of Dato-DXd vs docetaxel by assessment of OS in participants with TROP2 QCS-NMR positive non-squamous NSCLC without AGA
Tumor Imaging will be performed at Baseline and then at Every 6 weeks (± 7 days) from randomisation until RECIST 1.1-defined radiological PD by Investigator assessment (Week 6, Week 12, Week 18, Week 24, Week 30, Week 36)
Secondary Outcome
Outcome
TimePoints
To assess the superiority of Dato-DXd vs docetaxel by assessment of ORR in participants with TROP2 QCS-NMR positive non-squamous NSCLC without AGA
Tumor Imaging will be performed at Baseline & then at Every 6 weeks (± 7 days) from randomisation until RECIST 1.1-defined radiological PD by Investigator assessment (Week 6, Week 12, Week 18, Week 24, Week 30, Week 36)
To assess the superiority of Dato-DXd vs docetaxel by assessment of DoR in participants with TROP2 QCS-NMR positive non-squamous NSCLC without AGA
DoR is defined as the time from the date of first documented response until date of documented progression per RECIST 1.1, as assessed by BICR or death due to any cause. The analyses will include all randomised participants who have a response, as randomised, regardless of whether the participant withdraws from randomised therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST 1.1 progression.
The measure of interest is the median of DoR.
DoR by Investigator will be reported as a sensitivity analysis.
To assess the superiority of Dato-DXd vs docetaxel in terms of PFS2 in participants with TROP2 QCS-NMR positive non squamous NSCLC without AGA
PFS2 is defined as the time from randomisation to the earliest of
To evaluate exposure response relationship for efficacy and safety endpoints
Characterise population PK and its relationship with efficacy and safety endpoints, and evaluate the effects of covariates (eg, body weight) on PK, efficacy, and safety.
To investigate the immunogenicity of Dato DXd
Presence of ADAs for Dato-DXd (confirmatory results: positive or negative, titres)
To assess participant-reported lung cancer symptoms of NSCLC in participants treated with Dato-DXd relative to docetaxel
• Time to deterioration in pulmonary symptoms (dyspnoea, cough, and chest pain) as measured by the NSCLC-SAQ
• Time to deterioration is defined as the time from randomisation until the date of deterioration
Deterioration is defined as change from baseline that reaches an MCT.
The analyses will include all randomised participants.
The measure of interest is the HR of time to deterioration in pulmonary symptoms.
To assess participant-reported physical functioning in participants treated with Dato-DXd relative to docetaxel
• Time to deterioration in physical functioning as measured by PROMIS Short Form – Physical Function 8c.
• Time to deterioration is defined as the time from randomisation until the date of deterioration. Deterioration is defined as change from baseline that reaches an MCT.
The analyses will include all randomised participants.
The measure of interest is the HR of time to deterioration in physical functioning.
To assess participant-reported GHS/QoL in participants treated with Dato-DXd relative to docetaxel
• Time to deterioration in GHS/QoL as measured by the GHS/QoL scale from EORTC IL172
• Time to deterioration is defined as time from the date of randomisation to the date of deterioration
a Deterioration is defined as change from baseline that reaches an MCT.
The measure of interest is the HR of time to deterioration in GHS/QoL.
To assess TROP2 diagnostic test performance and relationship with other tumour-derived biomarkers or diagnostics tests, and support diagnostic test development
• Correlation of TROP2 expression at various cut offs with clinical response (PFS, OS, ORR, DoR, and other relevant efficacy endpoints).
• Diagnostic development and biomarker assay concordance analysis.
Analysis will include all screened participants or a subset of randomised participants, as appropriate.
Target Sample Size
Total Sample Size="400" Sample Size from India="28" 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)
18/11/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
31/10/2025
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="4" Months="0" 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
Overall Design Synopsis:
Brief Summary:
The purpose of this study is to measure efficacy and safety of Dato-DXd compared with docetaxel in participants with previously treated TROP2 QCS-NMR positive advanced or metastatic non-squamous NSCLC without AGA, and to assess the clinical performance of the investigational IVD device.
Study details include:
The expected study duration will be approximately 40 months from start of recruitment until the final analysis in the study.
The expected treatment and follow-up (28-day safety follow-up and survival follow-up) duration will be approximately 15 months.
The visit frequency will be every 3 weeks during treatment.
Disclosure Statement: This is a Phase III, 2arm, randomised, open label, multicentre study, assessingthe efficacy and safety of Dato DXd compared with docetaxel in participants with TROP2 QCS NMR positive advanced or metastatic non-squamous NSCLC.
Participant Population: The target population of interest in this study is restricted to participants with advanced or metastatic non-squamous NSCLC whose tumours are TROP2 QCS-NMR positive and without AGA (ie, alterations in genes with approved therapies, such as EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, KRAS G12C, HER2, or RET).
This study will enrol TROP2 QCS NMR positive participants based on results from an appropriately validated investigational TROP2 RxDx device in a Sponsor designated central laboratory. Tumour tissue testing for an absence of sensitising EGFR mutations, as well as ALK and ROS1 rearrangements, are mandatory for all participants. In addition, participants must have no known tumour genomic alteration results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted therapies. Local test results generated as part of SoC will be documented by the clinical study sites for AGA screening and enrolment decision. If local EGFR, ALK, and ROS1 testing are not available, prospective central testing will be offered in a Sponsor designated central laboratory. Central testing results from EGFR, ALK, and or ROS1 obtained during screening from another AstraZeneca study may be used for participants who meet the eligibility criteria for this study. The full list of eligibility criteria is included in Section 5.
Number of Participants: Approximately 1050 participants will be screened to randomise approximately 400 participants in a 1:1 ratioto receive either Dato DXd or docetaxel.
Note: ‘Screened’ means a participant’s, or their legally acceptable representative’s, agreement has been obtained to participate in a clinical study following completion of the informed consent process. Potential participants who are screened for the purpose of determining eligibility for the study, but are not randomised assigned in the study, are considered ‘screen failures’, unless otherwise specified by the protocol.
Study Arms and Duration:
Participants will be randomised in a 1:1 ratio to one of the following intervention groups:
Arm A: Participants in the Dato DXd group will receive 6 mg/kg Dato DXd (up to a maximum of 540 mg for patients Greater than or equal 90 kg) as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of every 21day cycle
Arm B: Participants in the docetaxel group will receive 75 mg/m2 as IV infusion Q3W on Day 1 of every 21day cycle
Randomisation will be stratified by:
Duration of prior anti programmed death protein 1 (PD1)/anti programmed death ligand 1 (PDL1) therapy (Less than 6 months Less than or equal 182 days versus Greater than or equal 6 months Greater than or equal 183 days)
Geographical region (US, EU, Canada versus rest of world RoW)
Participants will receive study intervention until RECIST 1.1 defined radiological progression by Investigator unless there is evidence of unacceptable toxicity, or if the participant requests to stop the study treatment.
Continuing study intervention beyond RECIST 1.1 defined progression of disease (PD) is not permitted in this study.
Follow up of Participants Post discontinuation of Study Intervention:
After study intervention discontinuation, all participants will undergo an end of treatment visit (within 35 days of discontinuation) and will be followed up for safety assessments 28 plus 7 days after their last dose of study intervention (ie, the safety follow up visit). If the day of discontinuation is over 35 days from last study intervention administration, then the safety follow up visit is not needed.
Participants who have discontinued study intervention in the absence of RECIST 1.1 defined radiological progression by Investigator assessment will be followed up with tumour assessments according to the Schedule of Activities (SoA) until RECIST 1.1 defined PD or death regardless of whether or not the participant started a subsequent anti-cancer therapy, unless they have withdrawn all consent to study-related assessments.
All participants will be followed up for survival status after intervention discontinuation every 12 weeks 14 days from the date of the safety follow-up until death, withdrawal of consent, or the end of the study (ie, progression/survival follow up), as per the SoA.
In addition, participants will be followed up for time to second progression or death (PFS2) every 12 weeks 14 days after initial objective PD until second progression on subsequent treatment, death, withdrawal of consent or end of the study.