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Alkylating agents

Dato-DXd + Pembrolizumab for Non-Small Cell Lung Cancer

Phase 3

Recruiting

Research Sponsored by Daiichi Sankyo

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has not been treated with systemic anticancer therapy for advanced or metastatic non-squamous NSCLC.

Has provided a formalin-fixed tumor tissue sample for the measurement of TROP2 protein expression and for the assessment of other exploratory biomarkers.

Must not have

Female who is pregnant or breastfeeding or intends to become pregnant.

Has active or uncontrolled hepatitis B or C infection.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 57 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests a new drug combo vs. chemo for lung cancer patients who have not yet received treatment.

Who is the study for?

Adults over 18 with advanced non-squamous NSCLC who haven't had systemic cancer treatment, have specific levels of TROP2 and PD-L1 proteins, no major gene mutations treatable by approved therapies, good performance status, and no significant health issues like uncontrolled heart disease or active infections. Pregnant women and those with certain lung diseases or recent vaccinations are excluded.

What is being tested?

The trial is testing the effectiveness of Dato-DXd combined with pembrolizumab versus pembrolizumab with pemetrexed and platinum chemo in first-line treatment for advanced NSCLC. It aims to see which combination works better for patients who meet specific biological criteria.

What are the potential side effects?

Potential side effects include reactions at the infusion site, fatigue, nausea, blood cell count changes leading to increased infection risk or bleeding problems. There's also a chance of lung issues like pneumonitis and other organ inflammation due to immune system activation.

Eligibility Criteria

Inclusion Criteria

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

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I haven't received systemic anticancer therapy for my advanced non-squamous NSCLC.

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I have given a tissue sample for cancer protein testing.

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My cancer can be measured by scans.

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My tumor's PD-L1 level is below 50%.

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I am 18 years old or older.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My lung cancer has been confirmed by a lab test and meets certain stage requirements.

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My cancer does not have any genetic changes treatable by approved drugs.

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My cancer does not have specific genetic changes treatable with targeted therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant, breastfeeding, nor planning to become pregnant.

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I do not have active or uncontrolled hepatitis B or C.

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I have received an organ or tissue transplant from another person.

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I have received treatment for advanced lung cancer before.

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I have or had lung inflammation that needed steroids, or it might be present but not confirmed.

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I do not have serious heart problems.

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I have severe lung problems due to another lung illness.

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I have a serious eye condition affecting my cornea.

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I have received specific treatments before.

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My HIV infection is not well controlled.

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I have an autoimmune disease.

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I had radiotherapy less than 4 weeks ago or received high-dose lung radiation in the last 6 months.

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I do not have active brain metastases or spinal cord compression.

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I have an immune system disorder or am on long-term steroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 57 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 57 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 57 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Malignant Neoplasms

Secondary study objectives

Disease Control Rate by BICR and Investigator in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)

Malignant Neoplasms

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Dato-DXd + Pembrolizumab + Platinum ChemotherapyExperimental Treatment4 Interventions

Participants will be randomized to receive 6.0mg/kg Dato-DXd plus 200 mg pembrolizumab plus platinum chemotherapy (cisplatin 75 mg/m\^2 or carboplatin area under the curve \[AUC) 5\]).

Group II: Dato-DXd + PembrolizumabExperimental Treatment2 Interventions

Participants will be randomized to receive 6.0mg/kg Dato-DXd plus 200 mg pembrolizumab.

Group III: Pembrolizumab + Pemetrexed + Platinum ChemotherapyActive Control4 Interventions

Participants will be randomized to receive 200 mg pembrolizumab plus 500 mg/m\^2 pemetrexed plus platinum chemotherapy (cisplatin 75 mg/m\^2 or carboplatin area under the curve \[AUC) 5\]).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3130

Carboplatin

2014

Completed Phase 3

~6120