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study to compare effectiveness and safety of two regimes in advanced stage non small cell lung cancer.

A Phase III Open label Randomized control study to compare efficacy and safety of Pemetrexed-Carboplatin versus Paclitaxel-Carboplatin as induction regimen in advanced Non-squamous Non-Small-Cell lung cancer

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/12/007605
Enrollment
200
Registered
2016-12-22
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- ADVANCED STAGE NON SQUAMOUS NON SMALL CELL LUNG CANCER Health Condition 2: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung

Interventions

Intervention1: Pemetrexed WITH Carboplatin: Pemetrexed (500 mg/m2) in 100 ml normal saline i.v. over 10 minute on day 1 of 21 days cycle Carboplatin at dose of (AUC -5) in 5 % dexrose i.v. over 2 hour

Sponsors

All INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -Age 18-65 years • Tissue diagnosis of Non-squamous Non-small cell lung cancer • Stage IIIB (not amenable for radical CTRT) and stage IV • Performance status ECOG 0, 1 and 2 • Normal renal and hepatic functions â?? Creatinine clearance >50ml/min â?? SGOT and SGPT < 2.5times of ULN

Exclusion criteria

Exclusion criteria: • Patients who have received prior chemotherapy • Already known EGFR/ALK mutation, if being considered for TKI • Symptomatic brain metastasis (Asymptomatic brain metastasis and stabilized brain metastasis after WBRT would be considered) • Immunosuppression (HIV, or other immunosuppressant medication) • Symptomatic neuropathy

Design outcomes

Primary

MeasureTime frame
To compare Progression Free Survival in both armsTimepoint: AFTER FOUR CYLES OF INDUCTION CHEMOTHERAPY—

Secondary

MeasureTime frame
1.To compare overall response rate in both arms 2. To compare toxicity profile in both arms 3. To compare Overall Survival in both arms 4. To compare disease control rate (CR/PR/SD) between the two induction treatment arms 5. To assess role of TS level and FRA level as predictive biomarkerTimepoint: AT THE END OF THE INDUCTION CHEMOTHERAPY—

Countries

India

Contacts

Public ContactDR PRABHAT SINGH MALIK

DR. BRAIRCH, AIIMS

ajayalwar01@gmail.com8826914083

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026