Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous NSCLC

← catalyst calendar

NCT04686305 · readout in 315 d

Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With Daiichi Sankyo.

Phase

Phase 1

Status

Recruiting

Study type

Interventional

Design

Randomized · None · Treatment

Enrollment

304estimated

Sites

Countries

Australia, Belgium, Brazil +16

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2021-03-09

actual

When the study began enrolling

Primary completion

2027-06-30

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2027-06-30

estimated

The whole study's end, after follow-up

First posted

2020-12-28

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-04-13

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Interventions

Drug: T-DXd — also filed as DS-8201a, Trastuzumab deruxtecan
Biological: Durvalumab — also filed as MEDI4736
Drug: Cisplatin
Drug: Carboplatin
Drug: Pemetrexed
Drug: Volrustomig — also filed as Other Name: MEDI5752
Drug: Rilvegostomig — also filed as Other Name: AZD2936

Primary outcome

what the primary-completion date above is the date OF

Frequency of AEs and SAEs

measured Safety and tolerability (and to determine RP2D) will be assessed for approximately 20 months from informed consent

Publications

PMID 41448488 — linked by the registry

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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