Gefitinib With or Without Chemotherapy in Brain Metastases From Non-small Cell Lung Cancer

Summary

This is a multi-center phase III randomized controlled study to assess the efficacy of Gefitinib alone and Gefitinib combination with Pemetrexed/platinum on patients with brain metastasis from non-small cell lung cancer(NSCLC) harboring EGFR mutation type by intracranial PFS(iPFS),also PFS ,DCR and OS.The side effect is evaluated as well.

Timeline

Start

2016-01

Primary completion

2022-06

Completion

2022-12

Outcome

Met primary endpoint

paper Gefitinib plus chemotherapy significantly improved intracranial PFS, PFS, and OS compared with gefitinib alone PMID 36753281 ↗

Publications

• Hou X, Li M, Wu G, Feng W, Su J, Jiang H, Jiang G, Chen J, Zhang B, You Z, Liu Q, Chen L. Gefitinib Plus Chemotherapy vs Gefitinib Alone in Untreated EGFR-Mutant Non-Small Cell Lung Cancer in Patients With Brain Metastases: The GAP BRAIN Open-Label, Randomized, Multicenter, Phase 3 Study. JAMA Netw Open. 2023 Feb 1;6(2):e2255050. doi: 10.1001/jamanetworkopen.2022.55050.

Drugs

Indications