A Study to Evaluate Camrelizumab Combined With Famitinib as Subsequent Therapy in Patients With Advanced NSCLC

NCT05106335 | Terminated Phase 3 FDA Drug

• 1 other identifier: SHR-1210-III-332
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, open-label, international, multi-center, phase III trial to evaluate the efficacy, and safety of camrelizumab combined with famitinib malate versus docetaxel as subsequent therapy in Advanced NSCLC.

Conditions

Advanced NSCLC

Outcome Measures

Primary Outcomes (1)

• OS

  OS is the time interval from the date of randomization to death due to any reason or lost of follow-up.

  up to 4 years

Secondary Outcomes (5)

• PFS

  up to 4 years

• ORR

  up to 4 years

• DoR

  up to 4 years

• DCR

  up to 4 years

• TTF

  up to 4 years

Study Arms (3)

Treatment Arm A

EXPERIMENTAL

camrelizumab + famitinib

Drug: camrelizumab + famitinib

Treatment Arm C

EXPERIMENTAL

famitinib

Drug: famitinib

Treatment Arm B

ACTIVE COMPARATOR

docetaxel

Drug: docetaxel

Interventions

camrelizumab + famitinib DRUG

camrelizumab for intravenous injection; famitinib malate capsules for oral administration

Treatment Arm A

famitinib DRUG

famitinib malate capsules for oral administration

Treatment Arm C

docetaxel DRUG

docetaxel for intravenous injection

Treatment Arm B

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed metastatic or recurrent non-small cell lung cancer.
• Failed previous platinum-based chemotherapy and anti-PD-(L)1 monoclonal antibody treatment.
• Have measurable disease based on RECIST v1.1.
• ECOG PS score: 0-1.
• Expected survival ≥ 3 months.
• Non-surgically sterilized female subjects or women of childbearing potential must be negative for a serum pregnancy test within 3 days prior to the first dose and must be non-lactating. Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to take highly effective contraceptive measures during the study period and until 6 months after the last study dose.
• Subjects must participate voluntarily, sign the ICF, have good compliance, and cooperate with follow-up visits.

You may not qualify if:

• Have uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites.
• Have known history of prior malignancy in the past 3 years.
• Have active pulmonary tuberculosis.
• Have clinical symptoms of the heart or heart diseases that are not well controlled.
• Have hypertension which cannot be well controlled by antihypertensives
• Urinalysis has indicated that the urine protein is ≥ ++ and quantitative test of urine protein has confirmed that the 24-h urine protein is \> 1.0 g.
• Have a thrombosis tendency or are currently receiving thrombolysis/anticoagulation therapy.
• Have received major surgery within 4 weeks prior to randomization; or palliative radiotherapy within 2 weeks prior to randomization; or have not recovered from the toxicities and/or complications of previous interventions to NCI-CTCAE Grade ≤ 1.
• Have known history of arterial/venous thrombosis within 6 months prior to randomization, such as cerebrovascular accidents, deep vein thrombosis and pulmonary embolism.
• Are currently participating and receiving study therapy or have participated in a study and received the last dose of study drug within 4 weeks (or 5 half-lives of the study drug) prior to randomization.
• Previous treatment with camrelizumab, docetaxel, and small-molecule VEGFR inhibitors including famitinib.
• Have other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Subei People's Hospital of Jiangsu Province

Yangzhou, Jiangsu, 225001, China

Location

MeSH Terms

Interventions

camrelizumab; famitinib; Docetaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Camrelizumab Combined with Famitinib Malate Versus Docetaxel

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: November 3, 2021
• Study Start: January 6, 2022
• Primary Completion: May 11, 2022
• Study Completion: May 11, 2022
• Last Updated: August 16, 2023

Record last verified: 2023-08

Locations

CN (1)