Combination Chemotherapy With or Without Anlotinib in the Maintenance Treatment of Non-Squamous Non-Small Cell Lung Cancer.

NCT04453423 | Unknown Phase 2

• 1 other identifier: AN001
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will compare maintenance therapy with anlotinib plus pemetrexed versus pemetrexed or anlotinib alone, in patients with Non-squamous Non-small cell lung cancer who have not progressed during first-line therapy with anlotinib + pemetrexed + carboplatin. The primary endpoint of the study is progression-free survival (PFS); the secondary endpoints are disease control rate (DCR), objective response rate (ORR) and overall survival (OS).

Conditions

Non-squamous Non-small-cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  PFS is defined as the time from the date of treatment to the first date of disease progression or death from any cause.

  6 months

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  each 42 days up to intolerance the toxicity or PD (up to 12 months)

• Disease control rate (DCR)

  each 42 days up to intolerance the toxicity or PD (up to 12 months)

• Overall Survival (OS)

  12 months

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  Until 30 day safety follow-up visit

Study Arms (4)

First-line Treatment

OTHER

Drug: Anlotinib + Pemetrexed+Carboplatin

Maintenance Treatment A

EXPERIMENTAL

Drug: Pemetrexed

Maintenance Treatment B

EXPERIMENTAL

Drug: Anlotinib + Pemetrexed

Maintenance Treatment C

EXPERIMENTAL

Drug: Anlotinib

Interventions

Anlotinib + Pemetrexed+Carboplatin DRUG

Anlotinib: 12mg, QD, PO, d1-14, 21 days per cycle Carboplatin: AUC 5 on day 1 of 21 days per cycle Pemetrexed: 500mg/m2 iv on day 1 of 21 days per cycle

First-line Treatment

Pemetrexed DRUG

500mg/m2 iv on day 1 of 21 days per cycle(maintenance phase)

Maintenance Treatment A

Anlotinib + Pemetrexed DRUG

Anlotinib:12mg, QD, PO, d1-14, 21 days per cycle(maintenance phase) Pemetrexed:500mg/m2 iv on day 1 of 21 days per cycle(maintenance phase)

Maintenance Treatment B

Anlotinib DRUG

12mg, QD, PO, d1-14, 21 days per cycle(maintenance phase)

Maintenance Treatment C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years and ≤ 75, ECOG PS: 0\~1, estimated survival duration more than 3 months;
• Subjects with histologically or cytologically confirmed locally advanced and/or advanced Non-squamous NSCLC;
• Signed and dated informed consent;
• adequate hematological, liver and renal function

You may not qualify if:

• prior chemotherapy or treatment with another systemic anti-cancer agent
• malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer or DCIS
• evidence of tumor invading major blood vessels
• current or recent use of aspirin (\>325mg/day) or full-dose anticoagulants or thrombolytic agents for therapeutic purposes
• history of haemoptysis \>/=grade 2
• clinically significant cardiovascular disease

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

MeSH Terms

Interventions

anlotinib; Pemetrexed

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Central Study Contacts

Renhua Guo, MD

CONTACT

025-68136360; rhguo@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2020
• First Posted: July 1, 2020
• Study Start: July 1, 2020
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: July 1, 2020

Record last verified: 2020-06