Datopotamab Deruxtecan vs Docetaxel for Lung Cancer

(TROPION-Lung17 Trial)

Recruiting at 160 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AstraZeneca

Must be taking: Platinum chemotherapy, Anti-PD-1/PD-L1

Must not be taking: Corticosteroids, Anticonvulsants

Disqualifiers: Squamous NSCLC, Brain metastases, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: Approximately 2.5 years

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

TROPION-Lung17 will measure the efficacy and safety of datopotamab deruxtecan (Dato-DXd) compared with docetaxel in patients with trophoblast cell surface protein 2 (TROP2) positive advanced or metastatic lung cancer without actionable genomic alterations (AGA).

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic non-squamous lung cancer that tests positive for TROP2, but without genomic changes treatable by targeted therapy. Participants must have tried other treatments first.

Inclusion Criteria

My cancer does not have specific genetic changes that can be treated with targeted therapies.

My lung cancer is advanced but doesn't have specific genetic changes treatable by targeted drugs.

My cancer tests negative for EGFR, ALK, and ROS1 genes.

Exclusion Criteria

I do not have an infection needing IV drugs.

My lung cancer is squamous, mixed NSCLC, or SCLC type.

My NSCLC can be treated with local therapy only.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either datopotamab deruxtecan or docetaxel as intravenous infusion every 3 weeks

Approximately 2.5 years

Every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Datopotamab Deruxtecan
• Docetaxel

Trial Overview

The study compares the effectiveness and safety of a new drug called Datopotamab Deruxtecan (Dato-DXd) to an established chemotherapy drug, Docetaxel, in patients with a specific type of lung cancer.

How Is the Trial Designed?

Group I: Arm A: Datopotamab deruxtecan (Dato-DXd) monotherapy Experimental Treatment 1 Intervention

Participants in the Dato-DXd monotherapy group will receive Dato-DXd as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.

Group II: Arm B: Docetaxel monotherapy Active Control 1 Intervention

Participants in the docetaxel monotherapy group will receive docetaxel as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Daiichi Sankyo

Industry Sponsor

Trials

443

Recruited

493,000+

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD