Conditions: Non-Small Cell Lung Cancer
Keywords: RRM1 ERCC1 Customized Chemotherapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 275
Healthy volunteers: no

Brief summary:
This is a clinical research study to evaluate if chemotherapy in the experimental arm (E) results in a better outcome compared to patients in the standard of care arm (C).

2:1 randomization to experimental arm (E) or standard arm (C). In arm E, treatment of dual-agent chemotherapy will be selected based on RRM1 and ERCC1 expression at the protein level. In arm C, treatment of dual-agent chemotherapy will be gemcitabine/carboplatin, i.e., standard of care.

Detailed description:
Before each cycle, blood tests, vital signs, interim medical history, and a physical exam will be performed. Patients will be carefully checked so that immediate intervention can be initiated should an adverse event (i.e. hypersensitivity) occur.

The last treatment cycle according to the study will be cycle #6, or any earlier cycle. Certain tests will be done within 28 days after the last drug infusion. These include physical exam, vital signs, temperature, weight, adverse event evaluation, imaging studies, and blood work.

The study doctor will see the participants every 6 to 8 weeks for at least 12 months after they start treatment. After that, the participants will be followed every 3 months for an additional 24 months.

Arms:
arm 1: Experimental Arm E.

Patients received treatment according to gene expression strata with four doublet regimens.

Low ERCC1 and Low RRM1 Group - Gemcitabine (G) and Carboplatin (Cb): GCb Group.

Low RRM1 and High ERCC1 Group - Gemcitabine (G) and Docetaxel (D): GD Group.

High RRM1 and Low ERCC1 Group - Docetaxel (D) and Carboplatin (Cb): DCb Group.

High ERCC1 and High RRM1 Group - Vinorelbine (V) and Docetaxel (D): DV Group. arm 2: Control Arm C: Gemcitabine and Carboplatin (GCb).

All patients in arm C were treated with GCb regardless of gene expression levels. Patients received up to 6 cycles, and no maintenance therapy was allowed.

Interventions: intervention 1: Docetaxel intervention 2: Vinorelbine intervention 3: Carboplatin intervention 4: Gemcitabine
Intervention descriptions: intervention 1: GD Group: 40 mg/m\^2 on days 1 and 8, every 21 days

DCb Group: 75 mg/m\^2 on day 1

DV Group: 50 mg/m\^2 on days 1 and 15, every 28 days intervention 2: DV Group: 35 mg/m\^2 on days 1 and 15 intervention 3: GCb Group: Area under the curve (AUC) 5 on day 1, every 21 days

DCb Group: AUC 6 on day 1, every 21 days

Control Arm: Patients received up to 6 cycles, and no maintenance therapy was allowed. intervention 4: GCb Group: 1,250 mg/m\^2 on days 1 and 8

GD Group: 1,250 mg/m\^2 on days 1 and 8

Control Arm: Patients received up to 6 cycles, and no maintenance therapy was allowed.

Protocol document: