Anlotinib Plus Pemetrexed or Pemetrexed for Previously Untreated Elderly (>=70) or PS=2 Non-squamous NSCLC

NCT03768037 | Unknown Phase 4

• 1 other identifier: CTONG1801
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the efficacy and safety of Anlotinib plus Pemetrexed as the 1-line treatment of patients with Platinum intolerant advanced non-squamous NSCLC, with Pemetrexed control.

Conditions

Advanced Non-squamous NSCLC

Outcome Measures

Primary Outcomes (1)

• Proportion of patients alive and progression free at 6 months (APF6)

  the number (%) of patients who are alive and progression free per RECIST 1.1 at 6 months after randomization per Kaplan-Meier estimate of progression free survival at 6 months.

  Estimated to be from baseline up to 2 years

Secondary Outcomes (4)

• Progression Free Survival(PFS)

  Estimated to be from baseline up to 2 years

• Overall Survival(OS)

  Estimated to be from baseline up to 2 years

• Disease Control Rate(DCR)

  Estimated to be from baseline up to 2 years

• Objective Response Rate(ORR)

  Estimated to be from baseline up to 2 years

Study Arms (2)

Anlotinib plus Pemetrexed

EXPERIMENTAL

Anlotinib plus Pemetrexed

Drug: Anlotinib plus Pemetrexed

Pemetrexed

OTHER

Pemetrexed

Drug: Pemetrexed

Interventions

Anlotinib plus Pemetrexed DRUG

Anlotinib p.o, qd and it should be continued until disease progress or unacceptable toxic effects. Pemetrexed 500 mg/m2 every 21 days for 4-6 cycles or unacceptable toxic effects

Anlotinib plus Pemetrexed

Pemetrexed DRUG

Pemetrexed 500 mg/m2 every 21 days for 4-6 cycles or unacceptable toxic effects

Pemetrexed

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥70 years old and ECOG PS=0-2 or ≥18 years old and ECOG PS=2
• Diagnosed with advanced or recurrent non-squamous NSCLC (phase IIIB/IV) through pathology, with measurable nidus(using RECIST 1.1)
• No prior systemic treatment for non-squamous NSCLC
• Negative in EGFR\&ALK\&ROS1
• Main organs function is normal

You may not qualify if:

• Have any habitus or medical history of hemorrhage, however severe it is; the patients who have non healing wounds, ulcer or fracture after any events with hemorrhage or bleeding
• Symptoms of brain metastases cannot be controlled and treated within less than 21 days
• Have participated in other clinical trials of anti-tumor medicine within 4 weeks
• Get any severe diseases or the ones that cannot be controlled

Sponsors & Collaborators

• Guangdong Association of Clinical Trials: lead

Study Sites (1)

Beijing Chest Hospital

Beijing, Beijing Municipality, 101149, China

RECRUITING

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

Xiaoqing Liu

CONTACT

86-010-89509324; liuxiaoqing@csco.org.cn

Shucai Zhang

CONTACT

86-010-89509324; sczhang6304@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 7, 2018
• Study Start: November 26, 2018
• Primary Completion: November 26, 2019
• Study Completion: November 26, 2020
• Last Updated: December 7, 2018

Record last verified: 2018-11

Locations

CN (1)