Safety and Effectiveness Study of Chemotherapy in Combination With Erlotinib,or Sequential Erlotinib for Treatment in Patients With NSCLC

Phase 2

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: docetaxel; Drug: pemetrexed; Drug: Erlotinib

• Registration Number: NCT02037997
• Lead Sponsor: Fudan University

Brief Summary

The purpose of this study is to evaluate and compare safety and effectiveness of Chemotherapy in Combination With Erlotinib,or Sequential Erlotinib for Treatment in Patients With EGFR - TKI Resistance of EGFR Mutations

Detailed Description

from the first cycle of treatment (day one) to two month after the last cycle

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-01-02
• Study First Submitted QC: 2014-01-15
• Study First Posted: 2014-01-16
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-22
• Last Update Posted: 2016-02-23
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Sign the informed consent
2. ≥18 years
3. According to RECIST 1.1 standard, at least one measurable lesions
4. Histology and cytology confirmed with unfavorable surgical locally advanced stage (stage IIIB) or metastatic NSCLC (IV), Sensitive EGFR gene mutation
5. Palliative treatment has received two medicine first-line platinum-based chemotherapy and EGFR - TKI second-line treatment and objective clinical benefit (CR, PR or SD is more than 6 months), RESIST standard curative effect evaluation for progress
6. PS=0,1,2
7. No serious blood, heart, lung, liver and kidney dysfunction, and immune deficiency
8. Hb≥9g/dL；WBC≥3*109/L，ANC≥1.5*109/L，PLT≥75*109/L
9. Men or women of childbearing age in the experiment are willing to take contraceptive measures
10. Estimated survival period for 3 months or more

Exclusion Criteria

1. The palliative chemotherapy ever use docetaxel and pemetrexed
2. small cell lung cancer non small cell hybrid
3. Women during pregnancy or lactation
4. In the past the anti-tumor treatment of any outstanding ease of > CTCAE 2 levels of toxicity
5. Ccr<30 ml/min (calculated by Cockcroft-Gault formula)
6. hepatic insufficiency： Tbil> 1.5×ULN ALT and AST > 2.5×ULN (Patients with liver metastasis>5×ULN) Alkaline phosphatase>2.5 ×ULN(Patients with liver metastasis>5×ULN)
7. Severe symptomatic heart disease
8. Symptomatic brain metastases
9. In the last 5 years have been or are suffering from other histological types of malignant tumor
10. There are serious or uncontrolled systemic diseases
11. During the study period planned radiotherapy on target lesion
12. During the study period, plans to use other antineoplastic therapy
13. Clinical study on treatment of 30 days beginning period prior to participate in any study drug

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
combination with Erlotinib	docetaxel	Erlotinib 150mg qd combination with docetaxel 75mg/m2 or pemetrexed 500mg/m2
combination with Erlotinib	pemetrexed	Erlotinib 150mg qd combination with docetaxel 75mg/m2 or pemetrexed 500mg/m2
combination with Erlotinib	Erlotinib	Erlotinib 150mg qd combination with docetaxel 75mg/m2 or pemetrexed 500mg/m2
sequential chemotherapy for Erlotinib	docetaxel	docetaxel 75mg/m2 or pemetrexed 500mg/m2，after PD，Erlotinib 150mg qd
sequential chemotherapy for Erlotinib	pemetrexed	docetaxel 75mg/m2 or pemetrexed 500mg/m2，after PD，Erlotinib 150mg qd
sequential chemotherapy for Erlotinib	Erlotinib	docetaxel 75mg/m2 or pemetrexed 500mg/m2，after PD，Erlotinib 150mg qd

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	from the first cycle of treatment (day one) to two month after the last cycle

Trial Locations

Locations (1)

Cancer hospital Fudan University; 🇨🇳 Shanghai, Shanghai, China