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?

This trial explores whether a new treatment, datopotamab deruxtecan (Dato-DXd), is effective and safe for individuals with advanced lung cancer that tests positive for the TROP2 protein. The trial compares this new treatment to docetaxel, a standard chemotherapy drug. It seeks participants with advanced non-squamous non-small cell lung cancer that has progressed despite previous treatments, including platinum-based chemotherapy and immunotherapy. Individuals with this type of lung cancer, which has worsened after earlier treatments, might find this trial suitable. As a Phase 3 trial, it represents the final step before FDA approval, offering access to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that datopotamab deruxtecan (Dato-DXd) is generally well-tolerated by patients with advanced lung cancer. One study found that 25.6% of patients experienced serious side effects related to the treatment, including lung problems linked to the drug. However, a higher percentage, 42.1%, of patients taking docetaxel, the comparison drug, experienced serious side effects.

Overall, datopotamab deruxtecan has demonstrated promising safety results compared to other treatments, though some risks remain. It is crucial to discuss potential side effects with healthcare professionals before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lung cancer?

Datopotamab Deruxtecan is unique because it combines an antibody with a chemotherapy payload, delivering treatment directly to cancer cells. Most treatments for lung cancer, like chemotherapy with drugs such as docetaxel, attack rapidly dividing cells broadly, which can affect healthy cells too. However, Datopotamab Deruxtecan specifically targets cancer cells with a new mechanism called an antibody-drug conjugate, potentially reducing harm to normal cells and leading to fewer side effects. Researchers are excited because this targeted approach may improve treatment effectiveness and quality of life for patients.

What evidence suggests that this trial's treatments could be effective for lung cancer?

Research has shown that datopotamab deruxtecan, or Dato-DXd, holds promise for treating advanced lung cancer. In one study, patients with advanced non-small cell lung cancer (NSCLC) lived for a median of 14.6 months. This trial will compare Dato-DXd with docetaxel, another treatment option. Another study found that Dato-DXd significantly slowed cancer growth compared to docetaxel, particularly in patients with a specific type of lung cancer tissue. Additionally, the treatment caused tumors to shrink in 35% of patients and helped control the disease in 78% of cases, indicating effective disease management. These results suggest that Dato-DXd could be a strong option for treating advanced lung cancer. ^{1 4 5 6 7}

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

Citations

1.

ascopubs.org

ascopubs.org/doi/10.1200/JCO-24-01544

Datopotamab Deruxtecan Versus Docetaxel for Previously ...

Dato-DXd significantly improved PFS versus docetaxel in patients with advanced/metastatic NSCLC, driven by patients with nonsquamous histology.

2.

astrazeneca.com

astrazeneca.com/content/astraz/media-centre/press-releases/2024/dato-dxd-showed-median-overall-survival-of-146-months-in-patients-with-advanced-nsclc-in-tropion-lung01-phase-iii-trial.html

Datopotamab deruxtecan showed median overall survival ...

Datopotamab deruxtecan showed median overall survival of 14.6 months in patients with advanced nonsquamous non-small cell lung cancer in TROPION-Lung01 Phase ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12603430/

Efficacy and safety of datopotamab deruxtecan in advanced ...

Datopotamab deruxtecan (dato-DXd) demonstrated an objective response rate of 35% and a disease control rate of 78% in advanced/metastatic non-small cell lung ...

4.

daiichisankyo.com

daiichisankyo.com/files/news/pressrelease/pdf/202409/20240909_E.pdf

Datopotamab Deruxtecan Showed Median Overall Survival ...

“TROPION-Lung01 showed a clinically meaningful trend towards improving the survival of patients with advanced or metastatic nonsquamous non- ...

5.

jto.org

jto.org/article/S1556-0864(25)00761-0/fulltext

A Pooled Analysis of Datopotamab Deruxtecan in Patients ...

The confirmed objective response rate was 43% (95% confidence interval [CI]: 34–52), including five complete responses (4%). Median duration of response was 7.0 ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39761483/

Results From the Phase II TROPION-Lung05 Study

Conclusion: Encouraging and durable antitumor activity was observed with Dato-DXd in this heavily pretreated advanced/metastatic NSCLC population with ...

7.

daiichisankyo.us

daiichisankyo.us/press-releases/-/article/datopotamab-deruxtecan-showed-median-overall-survival-of-14-6-months-in-patients-with-advanced-nonsquamous-non-small-cell-lung-cancer-in-tropion-lung0

Datopotamab Deruxtecan Showed Median Overall Survival ...

Datopotamab deruxtecan showed median overall survival of 14.6 months in patients with advanced nonsquamous non-small cell lung cancer in TROPION-Lung01 Phase 3 ...