lung-cancer
Conditions
Interventions
Sponsors
Chongqing Southwest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must be patients with IIIb, IIIc, IVa and IVb stage non-small cell lung cancer which are confirmed by histologic examination and cannot be resected by surgery; 2. Subjects are required and willing to undergo 4 to 6 cycles of pemetrexed plus platinum chemotherapy; 3. The mutation (alteration) status of EGFR, ALK, ROS1, RET, HER2, BRAF and MET genes of the subjects is unknown or no therapeutic gene mutation (alteration) is found in the test; 4. Aged at least 18 years; 5. The expected survival of the subjects must exceed 4 months; 6. The ECOG score of the subjects' physical condition must be 0 or 1, (Karnofsky score > 70); 7. One week before the enrollment, normal organs and bone marrow function of the subjects should meet the following standards: ? Peripheral neutrophil count >1,500×109/L; ? platelet>100,000×109/L; ? Total bilirubin: in normal range; ? AST (SGOT) /ALT (SGPT)<2.5 times ULN (The upper limit of normal); ? Creatinine=2.5 times ULN. 8. If a female subject is likely to become pregnant, her spouse must agree to use adequate birth-control measures (hormonal or condom birth control) during the study before the female subject is enrolled in the study. Once the female subject is pregnant at the time of the study or suspected pregnancy, her physician should be informed immediately; 9. One week before enrollment, the INR of subjects must be less than 1.5, and PT should not be higher than the upper limit of normal range; 10. Subjects must be able to understand and voluntarily sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects have uncontrollable complications, including but not limited to, ongoing active infection, congestive heart failure symptoms, unstable angina, liver or/and renal insufficiency, arrhythmia, or mental illness, are inconsistent with the study's treatment requirements; 2. A month before participating in the study, patients that were treated with immunotherapy, hormone therapy or radiation therapy are not eligible for this study. Note: subjects who have not recovered from adverse effects to the drug are also not eligible for this study; 3. Subjects who have participated in any other drug study test within one year; 4. Subjects who are allergic to pemetrexed or/and platinum-based drugs; 5. Female subjects who are pregnant or nursing; 6. subjects who are HIV-positive and undergoing combination anti-retroviral treatment. Note: Myelosuppression therapy can lead to potentially fatal infections; 7. Subjects who have received radiotherapy, chemotherapy, systemic anti-tumor treatment or targeted treatment; 8. Prior to or during the study, subjects who require other systemic anti-tumor therapy or targeted therapy; 9. Subjects who have severe adverse reactions to chemotherapy drugs; 10. Subjects who have highly expressed (>75%) RRM1, TUBB3 and ERCC1 gene in mRNA level.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median Tumor Progression-free Survival(PFS);objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;toxic and side effect; | — |
Countries
China
Contacts
Public ContactHAIDONG WANG
Chongqing Southwest Hospital
Outcome results
None listed