Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Open-label, Multi-center Phase III Study of Erlotinib Versus Gemcitabine/Carboplatin in Chemo-naive Stage IIIB/IV Non-Small Cell Lung Cancer Patients With EGFR Exon 19 or 21 Mutation (Optimal)
Brief Summary: Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKIs) such as erlotinib have proved effective in second or third line therapy for advanced non-small cell lung cancer(NSCLC).It is well tolerated without the side effects usually associated with chemotherapy. The mutations in EGFR exons 19 or 21 have been reported to be associated with efficacy of EGFR TKIs.Based on the encouraging preliminary results from the Spanish lung cancer group' prospective study reported that the efficacy of Tarceva as first line treatment for metastatic NSCLC patients with EGFR mutation would delay disease progression,prolong overall survival and be well tolerated, medium Progression-free survival(PFS) was around 12 months and OS reach 24 months，our study is designed to compare PFS between the patients with mutant EGFR treated by gemcitabine/carboplatin and those by erlotinib in the first-line setting. We assumed 11 months of PFS on Tarceva arm versus 6 months on chemotherapy arm with a=0.025(alpha-spend for an interim analysis), 80% power and 12 months enrolment period, 12 months FU duration to calculate the sample size. The sample size is 69 pairs. Considering about 10% drop-out rate, the final sample size is 152 patients.So, chemo-naive staged IIIb/IV patients with EGFR mutations in exon 19 or 21 will be enrolled into this open-label, randomized,multicenter phase III study.


Options:
A: Arm Label: erlotinib; Type: EXPERIMENTAL; Interventions: Drug: erlotinib | Arm Label: gemcitabine/carboplatin; Type: ACTIVE_COMPARATOR; Interventions: Drug: gemcitabine/carboplatin | Intervention Type: DRUG; Name: erlotinib; Assigned to Arm(s): erlotinib | Intervention Type: DRUG; Name: gemcitabine/carboplatin; Assigned to Arm(s): gemcitabine/carboplatin
B: Arm Label: Cilengitide + Temozolomide + Radiotherapy; Type: EXPERIMENTAL; Interventions: Drug: Cilengitide, Drug: Temozolomide, Radiation: Radiotherapy | Arm Label: Temozolomide + Radiotherapy; Type: ACTIVE_COMPARATOR; Interventions: Drug: Temozolomide, Radiation: Radiotherapy | Intervention Type: DRUG; Name: Cilengitide; Assigned to Arm(s): Cilengitide + Temozolomide + Radiotherapy | Intervention Type: DRUG; Name: Temozolomide; Assigned to Arm(s): Cilengitide + Temozolomide + Radiotherapy, Temozolomide + Radiotherapy | Intervention Type: RADIATION; Name: Radiotherapy; Assigned to Arm(s): Cilengitide + Temozolomide + Radiotherapy, Temozolomide + Radiotherapy
C: Arm Label: Rindopepimut/GM-CSF plus Temozolomide; Type: EXPERIMENTAL; Interventions: Drug: Rindopepimut (CDX-110) with GM-CSF, Drug: Temozolomide | Arm Label: KLH plus Temozolomide; Type: ACTIVE_COMPARATOR; Interventions: Drug: Temozolomide, Drug: KLH | Intervention Type: DRUG; Name: Rindopepimut (CDX-110) with GM-CSF; Assigned to Arm(s): Rindopepimut/GM-CSF plus Temozolomide | Intervention Type: DRUG; Name: Temozolomide; Assigned to Arm(s): KLH plus Temozolomide, Rindopepimut/GM-CSF plus Temozolomide | Intervention Type: DRUG; Name: KLH; Assigned to Arm(s): KLH plus Temozolomide
D: Arm Label: Arm I (radiation therapy, temozolomide, placebo); Type: ACTIVE_COMPARATOR; Interventions: Radiation: 3-Dimensional Conformal Radiation Therapy, Radiation: Intensity-Modulated Radiation Therapy, Other: Laboratory Biomarker Analysis, Other: Placebo, Other: Quality-of-Life Assessment, Drug: Temozolomide | Arm Label: Arm II (radiation therapy, temozolomide, bevacizumab); Type: EXPERIMENTAL; Interventions: Radiation: 3-Dimensional Conformal Radiation Therapy, Biological: Bevacizumab, Radiation: Intensity-Modulated Radiation Therapy, Other: Laboratory Biomarker Analysis, Other: Quality-of-Life Assessment, Drug: Temozolomide | Intervention Type: RADIATION; Name: 3-Dimensional Conformal Radiation Therapy; Assigned to Arm(s): Arm I (radiation therapy, temozolomide, placebo), Arm II (radiation therapy, temozolomide, bevacizumab) | Intervention Type: BIOLOGICAL; Name: Bevacizumab; Assigned to Arm(s): Arm II (radiation therapy, temozolomide, bevacizumab) | Intervention Type: RADIATION; Name: Intensity-Modulated Radiation Therapy; Assigned to Arm(s): Arm I (radiation therapy, temozolomide, placebo), Arm II (radiation therapy, temozolomide, bevacizumab) | Intervention Type: OTHER; Name: Laboratory Biomarker Analysis; Assigned to Arm(s): Arm I (radiation therapy, temozolomide, placebo), Arm II (radiation therapy, temozolomide, bevacizumab) | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Arm I (radiation therapy, temozolomide, placebo) | Intervention Type: OTHER; Name: Quality-of-Life Assessment; Assigned to Arm(s): Arm I (radiation therapy, temozolomide, placebo), Arm II (radiation therapy, temozolomide, bevacizumab) | Intervention Type: DRUG; Name: Temozolomide; Assigned to Arm(s): Arm I (radiation therapy, temozolomide, placebo), Arm II (radiation therapy, temozolomide, bevacizumab)

Answer: A