Fruquintinib Combined With Sintilimab and Chemotherapy in the Treatment of Non-Small Cell Lung Cancer

NCT04956146 | Unknown Phase 2

• 1 other identifier: HMPL-013-FLAG-L101
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

A phase II study to assess the efficacy and safety of Fruquintinib Combined With Sintilimab and Chemotherapy as a first-line treatment in patients with unresectable or metastatic advanced Wild-type Genotype non-squamous Non-small Cell Lung Cancer.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  To assess the efficacy of Fruquintinib Combined With Chemotherapy as second-

  up to 24 months

Secondary Outcomes (3)

• Objective response rate (ORR)

  up to 24 months

• Disease control rate (DCR)

  up to 24 months

• Overall Survival（OS）

  up to 24 months

Study Arms (1)

Fruquintinib Combined With Sintilimab and Chemotherapy

EXPERIMENTAL

Drug: Fruquintinib，Sintilimab，Pemetrexed，Carboplatin

Interventions

Fruquintinib，Sintilimab，Pemetrexed，Carboplatin DRUG

Fruquintinib,fruquintinib at the dose determined in phase safety lead-in,5mg-intermittent (2 weeks on/ 1 week off) ，po，every 3 weeks(q3w) ; Sintilimab at the dose 200mg，iv, d1, given every 3 weeks (q3w); Pemetrexed at the dose 500 mg/m2，iv，d1，given every 3 weeks (q3w); Carboplatin at the dose AUC=4\~5，iv，d1；given every 3 weeks (q3w); Maintenance treatment：After 4\~6 cycles of carboplatin treatment, Sintilimab 200mg, iv, d1, q3w；Fruquintinib RP2D intermittent(2 weeks on/1 weeks off), po，q3w； pemetrexed 500mg/m2, d1,iv, q3w until progressive disease, death from any cause, unacceptable toxicity or informed consent withdrawal

Fruquintinib Combined With Sintilimab and Chemotherapy

Eligibility Criteria

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

You may qualify if:

• Voluntary provision of informed consent.
• Males or females aged 18-75.
• Histological or cytologically confirmed NSCLC, metastatic or non-resectable (stage IIIB-Ⅳ).
• Not suitable for targeted therapy (patients with non-squamous NSCLC have no EGFR, ALK, gene mutation)
• At least one lesion can be measured by imaging.
• Have not received systemic treatment in the past.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
• Life expectancy ≥ 12 weeks.
• Female of childbearing age must have a negative pregnancy test (serum or urine) within 7 days before enrolment.

You may not qualify if:

• Histological or cytologically confirmed small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC.
• Diagnosed with other malignant diseases other than NSCLC within 5 years.
• Have participated in other interventional clinical research treatments now or within 4 weeks.
• Have previously received multi-targeted kinase inhibitors therapy.
• Have active autoimmune diseases requiring systemic treatment within 2 years.
• Received systemic glucocorticoid therapy or immunosuppressive therapy within 2 weeks.
• Clinically uncontrollable pleural effusion/abdominal effusion.
• Vaccinated vaccines or attenuated vaccines within 4 weeks before the group;
• Pregnant or breastfeeding females.
• Other serious hazards to the safety of patients.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Yongqian Shu, PhD

CONTACT

00862568306428; shuyongqian@csco.org.cn

Pei Ma, M.D.

CONTACT

00862568305931; mapei@jsph.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 9, 2021
• Study Start: February 2, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2024
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)