Personalized Therapy in Non-small Cell Lung Cancer (PTINCLC)

Guangzhou Medical University

Status and phase: Completed; Phase 2

Conditions: Carboplatin Adverse Reaction; Lung Cancer

Treatments: Drug: carboplatin, gemcitabine , pametrexed

Study type: Interventional

Funder types: Other

Identifiers

NCT01781988

GZMC12521

PT12521 (Other Identifier)

Details and patient eligibility

About

Excision repair cross complementing 1 (ERCC1) ribonucleotide reductase M1 (RRM1) and thymidylate synthase(TS) are molecular determinants that predict sensitivity or resistance to platinum agents 、 gemcitabine and pemetrexed respectively.

Tailored therapy using these molecular determinants suggested patient benefit in a previously reported phase 2 trial. Here, we designed a study for an individual patient analysis of prospectively accrued patients who were treated with the "personalized therapy" approach versus other standard approaches.

Full description

Patients who had nonsmall- cell lung cancer (NSCLC) performance status of 0/1 were accrued to 2 phase 2 clinical trials Trial A (carboplatin and chemotherapy individuation based on sensitivity marker ), Trial B (carboplatin non-individuation or chemotherapy non-individuation ).

Patients who were treated on Trials B were analyzed as the "standard therapy" group. Patients accrued to Trial A were called the "personalized therapy" group. disease free survival (DFS) was estimated using the Kaplan-Meier method.

Enrollment: 128 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically confirmed non-small cell lung cancer
2. age from 18 years to 75 years
3. ECOG Performance Status no more than 2
4. at least one appraisable lung focus of diameter≥ 10 mm by lung CT
5. Haemoglobin ≥10.0 g/dl, Absolute neutrophil count ≥(ANC) 1.5 x 109/L, platelets ≥100 x 109/L
6. Total bilirubin ≤1.5 x upper limit of normal (ULN)
7. ALT and AST < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases
8. Creatinine clearance ≥60ml/min (calculated according to Cockcroft-gault formula)
9. Informed consent should be obtained before treatment.

Exclusion criteria

1. Mixed non-adenocarcinoma cell lung cancer histology
2. Previous treatment for Systemic chemotherapy or local radiotherapy
3. Be allergic to chemotherapy drugs
4. second active primary malignancy or serious concomitant medical disease
5. difficulties with adequate follow-up

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups

A.individual therapy

Experimental group

Description:

Carboplatin was administrated at an area under the plasma concentration time curve (AUC) of 5 on day 1 every 21 days, while gemcitabine was administrated at a dose of 1250 mg/m2 on day 1 and 8 and pemetrexed was administrated at a dose of 500 mg/m2 on day 1.

Treatment:

Drug: carboplatin, gemcitabine , pametrexed

B. non-individualized therapy

Experimental group

Description:

Carboplatin was administrated at an area under the plasma concentration time curve (AUC) of 5 on day 1 every 21 days, while gemcitabine was administrated at a dose of 1250 mg/m2 on day 1 and 8 and pemetrexed was administrated at a dose of 500 mg/m2 on day 1.

Treatment:

Drug: carboplatin, gemcitabine , pametrexed