NCT04612751

Phase 1b Study of Dato-DXd in Combination With Immunotherapy With or Without Carboplatin in Advanced or Metastatic Non-Small Cell Lung Cancer

A Phase 1b, Multicenter, 2-Part, Open-Label Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Immunotherapy With or Without Carboplatin in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (Tropion-Lung04)

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will assess safety, tolerability, and treatment activity of datopotamab deruxtecan (Dato-DXd) in combination with immunotherapy with or without carboplatin in participants with advanced or metastatic non-small cell lung cancer (NSCLC).

Detailed description

The primary objective is to assess the safety and tolerability of Dato-DXd in combination with immunotherapy with or without 4 cycles of carboplatin in participants with advanced or metastatic NSCLC. Two dose levels of Dato-DXd will be studied in combination with immunotherapy (durvalumab, AZD2936, MEDI5752, or AZD7789) with or without 4 cycles of carboplatin in 15 study cohorts Each cohort will start with Part 1 (dose escalation or confirmation), where 3 to 9 participants will be assessed for dose-limiting toxicities (DLT) in the first cycle of treatment. if the DLT incidence rate meets the criteria based on the modified toxicity probability interval-2 (mTPI-2), then Part 2 (dose expansion) may be opened.

Conditions

• Advanced or Metastatic NSCLC

Interventions

Type	Name	Description
DRUG	Datopotamab deruxtecan	Intravenous infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle
DRUG	Durvalumab	Intravenous infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle
DRUG	Carboplatin	Intravenous infusion Q3W on Day 1 or Day 2 of each 21-day cycle
DRUG	AZD2936	Intravenous infusion prior to Dato-DXd every 3 weeks (Q3W) on Day 1 prior to Dato-Dxd of each 21-day cycle
DRUG	MEDI5752	Intravenous infusion prior to Dato-DXd every 3 weeks (Q3W) on Day 1 prior to Dato-Dxd of each 21-day cycle
DRUG	AZD7789	Intravenous infusion prior to Dato-DXd every 3 weeks (Q3W) on Day 1 prior to Dato-Dxd of each 21-day cycle

Timeline

• Start date: 2021-02-02
• Primary completion: 2026-05-04
• Completion: 2026-05-04
• First posted: 2020-11-03
• Last updated: 2026-04-06

Locations

42 sites across 8 countries: United States, Belgium, Italy, Japan, Poland, Spain, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study