ETOP 21-21 BOUNCE: A multicentre, randomised, phase II trial of brigatinib consolidation versus observation or durvalumab in patients with unresectable stage III NSCLC and ALK-rearrangement, after definitive chemo-radiotherapy.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502467-38-00

Acronym

ETOP 21-21 BOUNCE

Enrollment

Registered

2023-11-10

Start date

2024-02-22

Completion date

2024-09-30

Last updated

2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer (NSCLC)

Brief summary

Progression-free survival, according to RECIST v1.1, evaluated in the ITT cohort. PFS will be compared between the two arms.

Detailed description

Overall survival, CNS-relapse-free survival, Patterns of disease progression, Toxicity according to CTCAE v5.0

Interventions

DRUGBRIGATINIB

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free survival, according to RECIST v1.1, evaluated in the ITT cohort. PFS will be compared between the two arms.	—

Secondary

Measure	Time frame
Overall survival, CNS-relapse-free survival, Patterns of disease progression, Toxicity according to CTCAE v5.0	—

Countries

France, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026