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Anti-tumor antibiotic

Dato-DXd + Rilvegostomig for Lung Cancer (TROPION-Lung12 Trial)

Phase 3
Waitlist Available
Led By David Jones, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Unequivocal no evidence of disease at post-surgical
Histologically documented treatment-naive Stage I (T < 4 cm, AJCC 8th ed) adenocarcinoma NSCLC
Must not have
Sensitizing EGFR mutation and/or ALK alteration
Clinically significant corneal disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomisation up to approximately 10 years.
Awards & highlights

Summary

This trial is testing a new treatment called Dato-DXd along with rilvegostomig for patients with Stage I lung cancer who have had surgery to remove the tumor. The study will

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
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My surgery showed no signs of cancer remaining.
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My lung cancer is in an early stage and has not been treated yet.
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My lung cancer was completely removed by surgery.
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I am mostly active, expected to live more than 6 months, and have fully recovered from surgery.
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My cancer is either ctDNA positive or has high-risk features like VPI, LVI, or is high-grade.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has a specific change in the EGFR gene or ALK gene.
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I have a serious eye condition affecting my cornea.
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I have or had lung inflammation treated with steroids, or it's suspected but not confirmed by scans.
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I have serious lung problems.
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I do not have an active infection like TB, hepatitis, or uncontrolled HIV.
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I have a history of primary immunodeficiency.
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I do not have any severe illnesses like uncontrolled bleeding, infections, or heart disease.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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
4,368 Previous Clinical Trials
288,736,099 Total Patients Enrolled
Daiichi SankyoIndustry Sponsor
406 Previous Clinical Trials
448,544 Total Patients Enrolled
David Jones, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center, New York, United States of America
2 Previous Clinical Trials
800 Total Patients Enrolled
~440 spots leftby Nov 2031
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