Phase II Umbrella Study Directed by Next Generation Sequencing

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.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

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.

Sponsors & Collaborators

• Chinese Thoracic Oncology Group

  collaborator UNKNOWN

• Guangdong Association of Clinical Trials

  lead OTHER

Principal Investigators

• Yi-Long Wu · Guangdong Association of Clinical Trials

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-07-09

Primary Completion

2022-12-30

Completion

2024-12-30

Countries

• China

Study Locations