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Antibody-drug conjugate

Dato-DXd + Pembrolizumab for Advanced Lung Cancer (TROPION-Lung08 Trial)

Phase 3
Recruiting
Research Sponsored by Daiichi Sankyo, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has provided a formalin-fixed tumor tissue sample for the measurement of trophoblast cell surface protein 2 (TROP2) protein expression and for the assessment of other exploratory biomarkers.
Histologically documented NSCLC that meets specific staging and disease criteria.
Must not have
Has spinal cord compression or active and untreated central nervous system (CNS) metastases and/or carcinomatous meningitis.
Has received prior radiotherapy ≤4 weeks of start of study intervention or more than 30 Gy to the lung within 6 months of Cycle 1 Day 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 71 months
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial will compare the effectiveness of a new cancer drug, datopotamab deruxtecan, when used with pembrolizumab versus pembrolizumab alone in patients with advanced lung cancer.

Who is the study for?
This trial is for adults with advanced or metastatic non-small cell lung cancer (NSCLC) who haven't had previous systemic treatments. Participants must have high PD-L1 expression, good physical condition, adequate bone marrow function, and no significant heart issues. They should not have certain infections like hepatitis B/C or HIV, severe eye diseases, recent vaccines, autoimmune diseases, other cancers within a set time frame, or untreated brain metastases.
What is being tested?
The study compares the effectiveness of Dato-DXd combined with pembrolizumab versus pembrolizumab alone in treating NSCLC without specific genetic changes. It aims to determine which treatment works better for this type of lung cancer by randomly assigning participants to one of the two groups.
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as inflammation in various organs and infusion-related reactions. There may also be fatigue, blood disorders that affect how your body fights infection or clots bloods cells together after an injury.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have given a tissue sample for TROP2 protein testing.
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My lung cancer has been confirmed by a biopsy and meets certain stage criteria.
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My tumor shows high PD-L1 expression.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer does not have certain genetic changes according to tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have untreated brain metastases or spinal cord compression.
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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 am currently on IV medication for an uncontrolled infection.
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I have received specific treatments for my non-small cell lung cancer.
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I have an autoimmune disease.
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I have received a transplant from another person.
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I do not have serious heart problems.
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I do not have active or uncontrolled hepatitis B or C.
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I have received treatment for advanced lung cancer before.
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I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last week.
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I have a serious eye condition affecting my cornea.
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My HIV infection is not well controlled.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 71 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 71 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
Overall Survival (OS) in Participants With Non-Squamous Histology Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Progression-free Survival Based on Blinded Independent Central Review in Participants With Non-Squamous Histology Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Secondary study objectives
Disease Control Rate by BICR and Investigator in Participants with Non-Squamous Histology, and Separately for All Randomized Participants
Duration of Response by BICR and Investigator in Participants with Non-Squamous Histology, and Separately for All Randomized Participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) with Non-Squamous Histology, and Separately for All Randomized Participants
+8 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999
64%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Systemic infection
1%
Clostridium difficile colitis
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab + CRT Followed by Pembrolizumab
Placebo + CRT Followed by Placebo

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Pembrolizumab + Datopotamab Deruxtecan (Dato-DXd)Experimental Treatment2 Interventions
Participants will be randomized to receive 200 mg pembrolizumab followed by 6.0mg/kg Dato-DXd.
Group II: PembrolizumbActive Control1 Intervention
Participants will be randomized to receive 200 mg pembrolizumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~3130

Find a Location

Who is running the clinical trial?

Daiichi Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
422,180 Total Patients Enrolled
Daiichi SankyoLead Sponsor
423 Previous Clinical Trials
468,723 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,031 Previous Clinical Trials
5,188,920 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,425 Previous Clinical Trials
289,140,204 Total Patients Enrolled
Global Clinical LeaderStudy DirectorDaiichi Sankyo
165 Previous Clinical Trials
80,736 Total Patients Enrolled

Media Library

Datopotamab Deruxtecan (Antibody-drug conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT05215340 — Phase 3
Lung Cancer Research Study Groups: Pembrolizumab + Datopotamab Deruxtecan (Dato-DXd), Pembrolizumb
Lung Cancer Clinical Trial 2023: Datopotamab Deruxtecan Highlights & Side Effects. Trial Name: NCT05215340 — Phase 3
Datopotamab Deruxtecan (Antibody-drug conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05215340 — Phase 3
~396 spots leftby Feb 2028
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