Investigation-specific Appendix 1 to Master Protocol PLATFORMPANSC2001 (KALEIDOSCOPE) A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer - METalmark

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508256-19-00

Acronym

61186372PANSC2001

Enrollment

Registered

2024-05-03

Start date

2024-07-15

Completion date

Unknown

Last updated

2025-12-22

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

Conditions

Unresectable Metastatic Non-small Cell Lung Cancer

Brief summary

For Phase 1 Combination Dose Selection: - Incidence and Severity of AEs, including Dose Limiting Toxicities (DLTs) For Phase 2 Expansion: - Objective response rate (ORR) according to RECIST v1.1 by investigator review; confirmatory analysis may be performed using blinded independent central review (BICR)

Interventions

DRUGINC280

DRUGJNJ-61186372

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
For Phase 1 Combination Dose Selection: - Incidence and Severity of AEs, including Dose Limiting Toxicities (DLTs) For Phase 2 Expansion: - Objective response rate (ORR) according to RECIST v1.1 by investigator review; confirmatory analysis may be performed using blinded independent central review (BICR)	—

Countries

France, Germany, Italy, Poland, Spain

Outcome results

None listed

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