Trial Information

Status:

Open

Specialty:

Lung

Date Opened:

05/12/2024

Planned Close date:

27/08/2027

Sponsors:

AstraZeneca - UK

Site Recruitment:

2 /

5

Principal Investigator:

Dr Ruth Board

Study Title:

TROPION-Lung10

Contacts

Research Nurse / Study Coordinator:

Sirjana Devkota

Administrator:

Aaisha Khan

A Phase III, Randomised, Open-label, Multicentre, Global Study of Datopotamab Deruxtecan (Dato- DXd) in Combination With AZD2936 or AZD2936 Alone Versus Pembrolizumab for the First-line Treatment of Patients With Locally-advanced or Metastatic NSCLC PD-L1 =50% Without Actionable Genomic Alterations (TROPION-Lung10)

This is a Phase 3, randomised, open-label, three arm multicentre, global study assessing the efficacy and safety of the experimental arm (Dato-DXd in combination with AZD2936) compared with the active comparator regimen of pembrolizumab as first-line treatment of participants with locally-advanced or metastatic NSCLC without actionable genomic alterations in PD-L1 ≥ 50%. The AZD2936 monotherapy arm will be utilised to assess contribution of components of the experimental arm. Approximately 200 study sites in an estimated 20 countries are planned across Europe, North America (including the US and Canada), Latin America, Asia (including South Korea, Japan, and China), the Middle East, and South Africa.

1. Histologically or cytologically documented NSCLC that is (a) Stage IIIB or IIIC disease not amenable for surgical resection or definitive chemoradiation, or Stage IV metastatic NSCLC disease at the time of randomisation who have not received prior chemotherapy or other systemic therapy for first-line Stage IIIB, IIIC or IV NSCLC. (b) Lacks sensitizing EGFR mutation (c) no known genomic alterations.
2. ECOG 0-1.
3. FFPE tumour sample collected < 3 months prior to signing informed consent.
4. Tumour PD-L1 status defined as TC equal to or > 50%.
5. Adequate bone marrow, minimum life expectancy of 12 weeks.

1. Any evidence of diseases or history of allogenic organ transplant, which, in the investigator’s opinion, makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocol.
2. History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence, adequately resected basal cell carcinoma of the skin or squamous cell carcinoma of the skin, lentigo maligna that has undergone potentially curative therapy or adequately treated in situ disease without evidence of recurrence.
3. Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant.
4. Persistent toxicities caused by previous anti-cancer therapy, excluding alopecia or vitiligo, not yet improved to Grade ≤ 1 or baseline.
5. Active or prior documented autoimmune, connective tissue or inflammatory disorders, autoimmune pneumonitis and autoimmune myocarditis.
6. Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 7 days prior to randomisation.
7. History of leptomeningeal carcinomatosis.
8. Clinically significant corneal disease.