Clinical trial · Interventional
Customizing First Line Chemotherapy in Advanced Non-Small Cell Lung Cancer
A Pilot Study of Customizing First Line Chemotherapy in Advanced Non-Small Cell Lung Cancer Based on Molecular Markers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual rate
Summary
Brief summary (as posted)
The study aims at piloting the concept of customization of chemotherapy based on molecular markers in patients with stage IIIB (with pleural effusion) and IV with performance status ≤ 2 with pathologically proven non-small cell lung cancer (NSCLC). The study will not test or compare individual regimen but rather it will test the approach of customization concept as a whole. The results of this pilot study will help in designing more definitive trials in our patient population.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin, Gemzar, Docetaxel, Alimta | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cisplatin,Docetaxel,Gemzar, Premetrexed
- description
- Patients will receive treatment for up to six cycles of the assigned regimen unless there is disease progression or unacceptable toxicities. After treatment, the patients will be seen every 2 months for the first year, then every 3 months for the second year and every 6 months afterwards.
- interventionNames
- Drug: Cisplatin, Gemzar, Docetaxel, Alimta
Primary outcomes (1)
- measure
- Efficacy and Safety
- timeFrame
- 3 years
- description
- 1. Efficacy is measured by: * overall response rate (partial response and complete response) using RECIST Criteria * time to disease progression (TTP) * progression free survival (PFS) * overall survival (OS) 2. To evaluate the Number of participants with Adverse Events and Serious Adverse Events.Safety will include 5 parameters to be collected for all patients who receive the study regimen which are: * Adverse Events * Laboratory Assessments * Vital Signs * Physical Examinations * ECG
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Microscopic diagnosis of NSCLC stages IIIB (with malignant pleural effusion) and IV 2. Having adequate tissue sample to perform the markers testing 3. Age ≥ 18 years 4. No prior chemotherapy treatment for lung cancer (Surgery and radiotherapy are acceptable) 5. No other concurrent cancer treatment 6. Performance status of 0- 2 per ECOG scale (Appendix II) 7. Adequate laboratory values as follows as follows: Absolute neutrophil count ≥ 1500/mm3 Platelet count ≥100, 000/ mm3 Total bilirubin ≤ 1.25X institutional upper normal level AST and ALT ≤ 3 X institutional upper normal level Serum creatinine ≤ 1.5 X institutional upper normal level 8. Presence of measurable disease Exclusion Criteria: 1. Prior systemic treatment for lung cancer 2. History of hypersensitivity to drugs used 3. Diagnosis of other malignancy in the last 5 years excluding curatively treated non-melanoma skin cancer and in-situ cervical cancer 4. Medical illness that puts the patient at significant risk per investigator's discretion 5. Uncontrolled CNS disease. Patients with CNS metastatic disease treated with radiotherapy or surgery will be eligible if the CNS disease is stable 4 weeks after the treatment initiation without increase dose of steroids 6. Positive pregnancy test or refusal to use contraception during treatment. (Gynecology consultant for contraception)
References
Publications (0)
Data not yet available