NCT03574402

Phase II Umbrella Study Directed by Next Generation Sequencing

An Open-label, Multi-center, Phase II Umbrella Study to Assess Efficacy of Targeted Therapy or Immunotherapy Directed by Next Generation Sequencing (NGS) in Chinese Patients With Advanced NSCLC (TRUMP)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Guangdong Association of Clinical Trials · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II, umbrella trial study directed by next generation sequencing (NGS) works in Chinese patients with advanced stage NSCLC who never received any anti-tumor treatment. The purpose of this study is to evaluate efficacy of targeted therapies or immunotherapy to NSCLC patients whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the anti-tumor efficacy of targeted agents or checkpiont inhibitors in advanced stage NSCLC with genomic alteration. SECONDARY OBJECTIVES: I. To evaluate the clinical efficacy of targeted agents or checkpiont inhibitors in advanced stage NSCLC with genomic alteration. II. To evaluate safty and tolerence of targeted agents or checkpiont inhibitors in advanced stage NSCLC with genomic alteration.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Avitinib Maleate	300mg orally (PO) twice daily (BID) on day 1-28.
DRUG	Afatinib	40mg orally once a day, 28 days as one cycle.
DRUG	Crizotinib	250mg PO QD on days 1-28. 28 days as one cycle.
DRUG	X-396	225mg PO QD on days 1-28. 28 days as one cycle.
DRUG	Chidamide	30mg orally twice weekly, 28 days as one cycle.
DRUG	Pyrotinib Maleate	400mg PO QD on days 1-28. 28 days as one cycle.
DRUG	AZD3759	200mg PO BID on days 1-28. 28 days as one cycle.
DRUG	Pirotinib	60mg PO QD/40mg PO BID on days 1-28. 28 days as one cycle.
DRUG	Nimotuzumab	400mg, iv gtt. on day 1,8,15. 21 days as one cycle.
DRUG	Pemetrexed	500mg/m\^2, iv gtt. Q3W. 21 days as one cycle.
DRUG	Cisplatin	75mg/m\^2, iv gtt. Q3W on day1. 21 days as one cycle.
DRUG	Sintilimab	200mg iv gtt. Q3W on day1. 21 days as one cycle.
DRUG	Gemcitabine	1g/m\^2 iv gtt. on day1,8. 21 days as one cycle.
DRUG	Gemcitabine	1.25g/m\^2 iv gtt. on day1,8. 21 days as one cycle.
DRUG	Carboplatin	AUC5 iv gtt. Q3W on day1. 21 days as one cycle.

Timeline

• Start date: 2018-07-09
• Primary completion: 2022-12-30
• Completion: 2024-12-30
• First posted: 2018-07-02
• Last updated: 2022-12-06

Locations

1 site across 1 country: China