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

Phase 2

Recruiting

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: Fruquintinib，Sintilimab，Pemetrexed，Carboplatin

• Registration Number: NCT04956146
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-30
• Study First Submitted QC: 2021-06-30
• Study First Posted: 2021-07-09
• Status Verified: 2022-02
• Study Start: 2022-02-02
• Last Update Submitted: 2022-02-11
• Last Update Posted: 2022-03-02
• Primary Completion: 2023-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fruquintinib Combined With Sintilimab and Chemotherapy	Fruquintinib，Sintilimab，Pemetrexed，Carboplatin	-

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	up to 24 months	To assess the efficacy of Fruquintinib Combined With Chemotherapy as second-

Secondary Outcome Measures

Name	Time	Method
Overall Survival（OS）	up to 24 months	Overall survival is determined from the date of treatment to death from any cause or the last follow-up date
Objective response rate (ORR)	up to 24 months	CR + PR rate according to the RECIST version 1.1 guidelines.
Disease control rate (DCR)	up to 24 months	CR + PR + SD rate according to the RECIST

Trial Locations

Locations (1)

Jiangsu Province Hospital; 🇨🇳 Nanjing, Jiangsu, China