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Anti-tumor antibiotic

Dato-DXd + rilvegostomig for Non-Small Cell Lung Cancer (TROPION-Lung12 Trial)

Phase 3
Waitlist Available
Led By Enriqueta Felip, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Histologically documented treatment-naive Stage I (T \< 4 cm, AJCC 8th ed) adenocarcinoma NSCLC
2. Complete surgical resection (R0) of the primary NSCLC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomisation up to approximately 10 years.
Awards & highlights

Summary

This is a Phase III, randomised, open-label, multicentre, global study assessing the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig compared with SoC, after complete surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature.

Who is the study for?
This trial is for people who've had surgery to remove Stage I adenocarcinoma NSCLC and are either ctDNA-positive or have high-risk features. Participants should not have received prior systemic therapy for their lung cancer.
What is being tested?
The study compares adjuvant Dato-DXd with rilvegostomig versus standard chemotherapy drugs (like Pemetrexed, UFT, Etoposide) after tumor removal in patients with a specific type of lung cancer.
What are the potential side effects?
Potential side effects may include reactions at the infusion site, fatigue, nausea, hair loss from chemotherapy drugs like Etoposide and Carboplatin, and possible blood-related issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomisation up to approximately 10 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomisation up to approximately 10 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease-Free Survival (DFS) using BICR in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive or having at least one high-risk pathological feature treated with adjuvant Dato-DXd in combination with rilvegostomig relative to SoC
Secondary outcome measures
Immunogenicity
Overall Survival (OS) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive or having at least one high-risk pathological feature treated with adjuvant Dato-DXd in combination with rilvegostomig relative to SoC
Participant-reported GHS/QoL in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive or having at least one high-risk pathological feature treated with adjuvant Dato-DXd in combination with rilvegostomig relative to SoC
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: RilvegostomigExperimental Treatment1 Intervention
Participants in the rilvegostomig monotherapy group will receive rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W).
Group II: Dato-DXd + rilvegostomigExperimental Treatment2 Interventions
Participants in the Dato-DXd in combination with rilvegostomig group will receive Dato-DXd and rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W).
Group III: Standard of Care (SoC)Active Control6 Interventions
Patients in SoC group will undergo observation or will receive Investigator's Choice of Chemotherapy (ICC).

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,331 Previous Clinical Trials
288,639,425 Total Patients Enrolled
Daiichi SankyoIndustry Sponsor
400 Previous Clinical Trials
444,205 Total Patients Enrolled
Enriqueta Felip, MDPrincipal InvestigatorVall d'Hebron Hospital, Barcelona, Spain
1 Previous Clinical Trials
624 Total Patients Enrolled
~440 spots leftby Nov 2031
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