A Clinical Trial of Fruquintinib in Patients With Advanced Non-small Cell Lung Cancer

NCT02590965 | Completed Phase 2

• 1 other identifier: 2014-013-00CH1
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 12

Brief Summary

This is a randomized, double-blind, placebo-controlled, multi-center Phase II clinical trial to evaluate the efficacy and safety of Fruquintinib plus best supportive care in patients with advanced non-squamous non-small cell lung cancer who failed to second-line standard chemotherapy.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progressive free survival (PFS)

  To compare the Progressive Free Survival (PFS) of Fruquintinib plus best supportive care (BSC) versus placebo plus BSC in patients advanced non-squamous NSCLC patients who failed to standard second-line chemotherapy according to RECIST 1.1

  measured every 4 weeks at first 2 cycles and every 8 weeks since the third cycle from randomization to disease progression, assessed up to one year

Secondary Outcomes (4)

• Objective response rate (ORR)

  measured every 4 weeks at first 2 cycles and every 8 weeks since the third cycle from randomization to disease progression, assessed up to one year

• Disease control rate (DCR)

  measured every 4 weeks at first 2 cycles and every 8 weeks since the third cycle from randomization to disease progression, assessed up to one year

• Overall survival (OS)

  every 2 months from randomization to death, assessed up to one year

• safety and tolerability by incidence, severity and outcome of adverse events

  From randomization to 30 days after last dose

Study Arms (2)

Control Group

PLACEBO COMPARATOR

Placebo is a capsule in the form of 1mg and 5 mg, orally, once daily, 3 weeks on/1week off with best supportive care.

Drug: Placebo

Treatment Group

EXPERIMENTAL

The subjects will receive oral Fruquintinib at fasting state 5mg+best supportive care, once daily for the first 3 consecutive weeks and dose holiday for 1 week according to their dose regimens until the occurrence of disease progression, unacceptable toxicity, or withdrawal of consent

Drug: Fruquintinib

Interventions

Fruquintinib DRUG

After checking eligibility criteria, subjects will be randomized into Fruquintinib plus best supportive care group (treatment group) or placebo plus best supportive care group (control group) in a ration of 2:1.

Also known as: HMPL-013

Treatment Group

Placebo DRUG

Placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/1 week off

Also known as: HMPL-013-placebo

Control Group

Eligibility Criteria

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

You may qualify if:

• Fully understand the study and sign the informed consent form voluntarily;
• Histologically and/or cytologically diagnosed with local advanced and/or metastatic stage IIIB/IV non-squamous NSCLC;
• Previously failed to two chemotherapy regimens(treatment failure is defined as disease progression or intolerable toxicity), patients with positive EGFR mutation permitted to treated by EGFR-TKI previously; patients with EGFR wild type or unknown whether or not treated by EGFR-TKI previously;
• Aged 18-75 years (inclusive);
• Body weight ≥40 kg;
• Evident measurable lesion(s) (according to RECIST1.1);
• ECOG Performance Status 0-1;
• Expected survival \>12 weeks

You may not qualify if:

• Treatment in another clinical trials in the past 3 weeks; or treatment with systemic anti-tumor chemotherapy, radiotherapy or biotherapy within 3 weeks prior to administration of the study drug;
• Previous therapy with VEGF/VEGFR inhibitors;
• Unrecovered from toxicity caused by previous anti-cancer treatment (CTCAE \>grade 1), or not completely recovered from previous surgery;
• Previous active brain metastasis (without radiotherapy previously, or symptoms stable \< 4 weeks, or with clinical symptoms, or with medication to control symptoms);
• Other malignancies except basal cell carcinoma or cervical carcinoma in situ in the past 5 years;
• Uncontrolled clinical active infection, e.g. acute pneumonia and active hepatitis B;
• Dysphagia or known drug malabsorption;
• Present active duodenal ulcer, ulcerative colitis, intestinal obstruction and other gastrointestinal diseases or other conditions that may lead to gastrointestinal bleeding or perforation according to the investigators' judgment; or with a history of intestinal perforation or intestinal fistula;
• Have evidence or a history of thrombosis or bleeding tendency, regardless of seriousness;
• Stroke and/or transient ischemic attack within 12 months prior to enrollment;
• Appropriate organ function. Patients with any of the following conditions will be excluded:
• Absolute neutrophil count (ANC) \<1.5×109/L, platelet \<100×109/L or hemoglobin \<9 g/dL within 1 week prior to enrollment;
• Serum total bilirubin \>1.5 upper limit of normal (ULN), alanine transaminase and aspartate transferase \>1.5×ULN; ALT and AST \> 3×ULN in patients with liver metastasis;
• Electrolyte abnormality of clinical significance;
• Blood creatinine \>ULN and creatinine clearance \<60 ml/min;

Sponsors & Collaborators

• Hutchison Medipharma Limited: lead
• Shanghai Chest Hospital: collaborator

Study Sites (12)

307 Hospital of PLA

Beijing, Beijing Municipality, 100071, China

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Beijing Chest Hospital

Beijing, Beijing Municipality, 101149, China

Location

Xi Nan Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400038, China

Location

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

Location

Nantong Tumor Hospital

Nantong, Jiangsu, 226000, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Linyi Tumor Hospital

Linyi, Shandong, 276001, China

Location

The Cancer Hospital of Fudan University

Shanghai, Shanghai Municipality, 200000, China

Location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

West China Hospital

Chengdu, Sichuan, 610041, China

Location

The First Affiliated Hosptial of College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Related Publications (1)

• Lu S, Chang J, Liu X, Shi J, Lu Y, Li W, Yang JJ, Zhou J, Wang J, An T, Yang L, Liu Z, Zhou X, Chen M, Hua Y, Su W. Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study of Fruquintinib After Two Prior Chemotherapy Regimens in Chinese Patients With Advanced Nonsquamous Non-Small-Cell Lung Cancer. J Clin Oncol. 2018 Apr 20;36(12):1207-1217. doi: 10.1200/JCO.2017.76.7145. Epub 2018 Mar 12.

  PMID: 29528793 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

HMPL-013

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2015
• First Posted: October 29, 2015
• Study Start: May 29, 2014
• Primary Completion: August 7, 2015
• Study Completion: February 10, 2017
• Last Updated: February 13, 2020

Record last verified: 2020-02

Locations

CN (12)