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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

A Single Arm,Open-label, Study of Fruquintinib Combined With Sintilimab and Chemotherapy in Patients With Unresectable or Metastatic Advanced Wild-type Genotype Non-squamous Non-small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04956146
• Other study ID #: HMPL-013-FLAG-L101
• Status: Recruiting
• Phase: Phase 2
• Start date: February 2, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2022
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Yongqian Shu, PhD
• Phone: 00862568306428
• Email: shuyongqian[@]csco.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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-?).

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Jiangsu Province Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)	To assess the efficacy of Fruquintinib Combined With Chemotherapy as second-	up to 24 months
Secondary	Objective response rate (ORR)	CR + PR rate according to the RECIST version 1.1 guidelines.	up to 24 months
Secondary	Disease control rate (DCR)	CR + PR + SD rate according to the RECIST	up to 24 months
Secondary	Overall Survival(OS)	Overall survival is determined from the date of treatment to death from any cause or the last follow-up date	up to 24 months