MedTrace Logo

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

NCT04453423 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2020-07-01

No results posted yet for this study

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

Interventions

DRUG

Anlotinib + Pemetrexed+Carboplatin

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

DRUG

Pemetrexed

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

DRUG

Anlotinib + Pemetrexed

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)

DRUG

Anlotinib

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

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2022-07-01
Completion
2022-07-01

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04453423 on ClinicalTrials.gov