Beamion LUNG-1: A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene)

Conditions

• Neoplasm Metastasis
• Non-Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• zongertinib — DRUG
  zongertinib

Study Details

The study has 2 parts. The first part is open to adults with different types of advanced cancer (solid tumours with changes in the HER2 gene) for whom previous treatment was not successful. The second part is open to people with non-small cell lung cancer with a specific mutation in the HER2 gene. The purpose of the first study part is to find the highest dose of a medicine called zongertinib the participants can tolerate. Once this dose is found, it will be used in the second study part to test whether zongertinib can make tumours shrink. In this study, zongertinib is given to people for the first time. Participants take zongertinib as tablets once a day or twice a day. The participants are in the study for as long as they benefit from and can tolerate treatment. Study doctors regularly check the participants' health and monitor the tumours. The doctors also take note of any unwanted effects that could have been caused by zongertinib.

Key Dates

First listed

May 14, 2021

Start date

Jul 2, 2021

Status verified

Jul 2026

Primary completion

Dec 30, 2026

Completion

Aug 30, 2028

Study Design

Enrollment

608 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Phase Ia - Dose escalation part
  Consecutive cohorts of patients treated with escalating doses of BI 1810631 monotherapy.
• Experimental: Phase Ib - Dose expansion part: Cohort 1
• Experimental: Phase Ib - Dose expansion part: Cohort 2
• Experimental: Phase Ib - Dose expansion part: Cohort 3
• Experimental: Phase Ib - Dose expansion part: Cohort 4
• Experimental: Phase Ib - Dose expansion part: Cohort 5
• Experimental: Phase Ib - Dose expansion part: Cohort 6
  Cohort only in the United States of America (USA)
• Experimental: Phase Ib - Dose expansion part: Cohort 7
  Cohort only in Japan
• Experimental: Phase Ib - Dose expansion part: Cohort 8
  Cohort only in the United States of America (USA)
• Experimental: Phase Ib - Dose expansion part: Cohort 9
  Cohort only in China

Primary Outcome Measure

Phase Ia: Maximum Tolerated Dose (MTD) [ Time Frame: At the end of Cycle 1 (each cycle is 21 days). ]

Locations (20)

Find similar trials in Birmingham, AL

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