Paclitaxel/Carboplatin (PC) Followed by Gefitinib Versus PC in Advanced Non-small Cell Lung Cancer

Summary

This study compares paclitaxel/carboplatin (PC) to PC chemotherapy followed by gefitinib for 2 weeks in patients with Non-small Cell Lung Cancer (NSCLC) without epidermal growth factor receptor (EGFR) mutations. Expanded acronym : \[P\]aclitaxel/Ca\[r\]boplatin (PC) followed by Gef\[i\]tinib in A\[d\]vanc\[e\]d Non-small Cell Lung Cancer (NSCLC): Randomized phase II study.

Timeline

Start

2009-12

Primary completion

2012-02

Completion

2012-12

Outcome

Missed primary endpoint

paper for the PCG arm and 39.5 % (95 % CI 25.0-55.6 %) for the PC arm (P = 0.826). PMID 26493267 ↗

paper PCG did not improve ORR, PFS, and OS compared to PC chemotherapy alone PMID 26493267 ↗

Publications

• Choi YJ, Lee DH, Choi CM, Lee JS, Lee SJ, Ahn JH, Kim SW. Randomized phase II study of paclitaxel/carboplatin intercalated with gefitinib compared to paclitaxel/carboplatin alone for chemotherapy-naive non-small cell lung cancer in a clinically selected population excluding patients with non-smoking adenocarcinoma or mutated EGFR. BMC Cancer. 2015 Oct 22;15:763. doi: 10.1186/s12885-015-1714-y.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Carboplatin	Small molecule	5 unknown	Intravenous
Subject	Gefitinib	Small molecule	250 mg	Oral
Comparator	Paclitaxel	Small molecule	175 mg/m2	Intravenous

Indications