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

Phase 3

Completed

• Conditions: Malignant neoplasm of unspecifiedpart of bronchus or lung,

• Registration Number: CTRI/2016/12/007605
• Lead Sponsor: All INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI

Brief Summary

Lung cancer is the leading cause of cancer-related deaths worldwide. Non-small cell lung cancer (NSCLC), accounts for about 85% of all lung cancers. Platinum base chemotherapy is the standard first-line treatment for patients of advanced NSCLC who are negative for the EGFR mutation and ALK rearrangement. There are

various Cisplatin and Carboplatin based regimen approved for treatment of this group. To know which regimen is better Schiller et al, conducted a randomized clinical trial. In this trial they compared the efficacy of four doublet regimens Cisplatin plus gemcitabine, cisplatin plus docetaxel, carboplatin plus paclitaxel, or cisplatin plus paclitaxel in patients with advanced non–small-cell lung cancer. None of four chemotherapy regimens offered a significant advantage over the others. In a phase III study Scagliotti et al. found that pemetrexed plus cisplatin was noninferior to gemcitabine plus cisplatin in unselected patients with advanced-stage NSCLC. On subgroup analysis survival was significantly superior for patients with non-squamous histology who were treated with pemetrexed plus cisplatin. In phase III RCT (Point Break trial) Patel et al. compared the efficacy and safety of pemetrexed plus carboplatin plus bevacizumab followed by pemetrexed plus bevacizumab with paclitaxel plus carboplatin plus bevacizumab followed by bevacizumab in patients with advanced nonsquamous non–small-cell lung cancer. There was no difference in overall survival but PFS was significantly improved with PemCBev.  There is no trial that has compared efficacy and safety of Paclitaxel-Carboplatin versus Pemetrexed-Carboplatin. In current study we will compare the efficacy and safety of Pemetrexed-Carboplatin versus Paclitaxel-Carboplatin as induction regimen in advanced Non-squamous Non-Small-Cell lung cancer. We hypothesized that in advanced non-squamous NSCLC, four cycles of induction chemotherapy with pemetrexed and carboplatin is superior to 4 cycles of paclitaxel and carboplatin in terms of progression free survival. Several clinical trials have shown that maintenance chemotherapy is beneficial in non squamous NSCLC. Several recent studies reported that low TYMS expression was associated with better response and/or survival when treated with pemtrexed-based regimens in NSCLC patients. But some other studies did not show the significant association between TYMS expression and efficacy of pemtredxed-based chemotherapy in NSCLC. Folate receptor alpha is a glycosyl phosphatidyl inositol (GPI) anchored cell surface protein that assists in uptake of antifolates via receptor-mediated endocytosis. Some studies reported that High FRA expression associated with better response to pemetrexe. In our study we will also assess role of TS level and FRA level as predictive biomarker.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-26
• Study Completion: 2019-01-31
• Last Update Posted: 2020-03-02

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

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 – Creatinine clearance >50ml/min – SGOT and SGPT < 2.5times of ULN.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare Progression Free Survival in both arms	AFTER FOUR CYLES OF INDUCTION CHEMOTHERAPY

Secondary Outcome Measures

Name	Time	Method
1.To compare overall response rate in both arms	2. To compare toxicity profile in both arms

Trial Locations

Locations (1)

ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI; 🇮🇳 Delhi, DELHI, India

ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI

🇮🇳Delhi, DELHI, India

DR PRABHAT SINGH MALIK

Principal investigator

9968325318

drprabhatsm@gmail.com