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

NCT ID: NCT04956146

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-02
• Study Completion Date: 2024-09-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fruquintinib Combined With Sintilimab and Chemotherapy

Group Type: EXPERIMENTAL

Fruquintinib，Sintilimab，Pemetrexed，Carboplatin

Intervention Type: 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

Interventions

Fruquintinib，Sintilimab，Pemetrexed，Carboplatin

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yongqian Shu, PhD

Role: CONTACT

shuyongqian@csco.org.cn

00862568306428

Pei Ma, M.D.

Role: CONTACT

mapei@jsph.org.cn

00862568305931

Facility Contacts

Pei Ma, M.D.

Role: primary

mapei@jsph.org.cn

008668305931

Other Identifiers

HMPL-013-FLAG-L101

Identifier Type: -

Identifier Source: org_study_id