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Non-Small Cell Lung Cancer Stage III | Anlotinib After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer(ALTER-L029)

Non-Small Cell Lung Cancer Stage III research study

What is the primary objective of this study?

Evaluate the efficacy and safety of Anlotinib following concurrent chemoradiation in patients with stage III unresectable non-small cell lung cancer

Who is eligible to participate?

Inclusion Criteria: - 1.Age at least 18 years. - 2.Documented evidence of NSCLC (locally advanced, unresectable, Stage III). - 3.Patients must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy. - 4.ECOG PS : 0 to 1. - 5.Estimated life expectancy of more than 12 weeks. Exclusion Criteria: - 1.Prior exposure to any anti-angiogenesis drugs. - 2.Central lung carcinoma along with large vessels or tumor with cavum or necrosis. - 3.Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV. - 4.Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy. - 5.Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or COPD.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Non-Small Cell Lung Cancer Stage III

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:AnlotinibAnlotinib 12mg p.o, qd

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

AnlotinibAnlotinib p.o, qd. Treatment from Day 1 of randomization(after concurrent chemoradiation 4-6 weeks) to disease progress or untolerated toxicity or consent withdrawal. The 2:1 ratio (Anlotinib to blank).

BlankNo intervention from Day 1 of randomization(after concurrent chemoradiation 4-6 weeks) .The 2:1 ratio (Anlotinib to blank).

Study Status

Not yet recruiting

Start Date: November 30, 2018

Completed Date: November 30, 2021

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Progression Free Survival (PFS)

Secondary Outcome: Disease Control Rate at 6 months(DCR6)

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Anhui Shi, MD

Collaborator:

More information:https://clinicaltrials.gov/show/NCT03743129

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