Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05001724
Other study ID # KN046-302
Secondary ID
Status Terminated
Phase Phase 2/Phase 3
First received
Last updated
Start date October 28, 2021
Est. completion date April 7, 2023

Study information

Verified date April 2023
Source Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a phase 2/3, multicenter, randomized, open, positive-controlled study of patients with advanced non-small cell lung cancer whose disease has progressed after prior anti-PD-(L)1 therapy. Subjects should have documented progressive disease during prior treatment with first- or second-line PD-(L)1 and platinum-containing dual-agent chemotherapy.Subjects will be randomized to two treatment groups in a 1:1 ratio. Treatment Group: KN046 5mg/kg Q3W + lenvatinib recommended for phase III dose (RP3D) every day. Control group: Docetaxel 75mg/m2 Q3W .


Recruitment information / eligibility

Status Terminated
Enrollment 16
Est. completion date April 7, 2023
Est. primary completion date February 13, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion criteria: - Has a histologically confirmed or cytologically confirmed diagnosis of advanced NSCLC; - Non-squamous non-small cell lung cancer, no EGFR mutation or ALK rearrangement or ROS1 fusion, no known RET fusion or MET14 exon jump mutation; Squamous non-small cell lung cancer with no known EGFR mutation or ALK rearrangement or ROS1 fusion /RET fusion /MET14 exon jump mutation; - Has received prior systemic treatment with first- or second-line PD-(L)1 and platinum-containing dual-agent chemotherapy for their advanced NSCLC; - Has measurable disease; - Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status; - Has adequate organ function; - Has a life expectancy of at least 3 months; - If female of childbearing potential, have a negative serum pregnancy test within 7 days prior to first trial treatment; - If female of childbearing potential or a male subject with a partner with childbearing potential, be willing to use a highly effective method of contraception (with a failure rate of less than 1.0% per year) from first study treatment to 24 weeks after completion of the trial treatment. Exclusion Criteria: - Untreated active central nervous system metastasis or leptomeningeal metastasis; - Is currently participating and receiving an investigational drug or has participated in a study of an investigational drug within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first dose of trial treatment; - Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first administration of trial treatment and/or if the subject has not fully recovered from the surgery within 4 weeks of the first administration of trial treatment; - Curative radiation within 3 months of the first dose of trial treatment; - Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement doses, equivalent to < 10 mg prednisone daily, inhaled steroids and topical use of steroids); - Vaccination within 28 days of the first administration of trial treatment, except for administration of inactivated vaccines; - Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management; - History or current active autoimmune disease that might deteriorate when receiving an immunostimulatory agent; - Previous malignant disease; - History of uncontrolled intercurrent illness; - Prior therapy with any antibody/drug targeting T cell coregulatory proteins; - Has received treatment with lenvatinib or docetaxel or VEGFR-TKI; - Known severe hypersensitivity reactions to antibody drug; - Is pregnant or breastfeeding; - Other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
KN046
KN046 is 5 milligram per kilogram, every 3 weeks.
Drug:
Lenvatinib
Lenvatinib is RP3D milligram per day, every day.
Docetaxel
Docetaxel is 75 milligram per Square meter, every 3 weeks.

Locations

Country Name City State
China Shanghai Pulmonary Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Safety endpoint Serious adverse events (SAE), changes and abnormal findings in laboratory test, vital sign and physical examination. up to 2 years
Primary DLT Dose limit toxicity (phase 2) 28 days or 21 days
Primary OS Overall survival (OS) was defined as the time from randomization to death due to any cause (phase 3). up to 2 years
Primary PFS Progression-free survival (PFS) was defined as the time from randomization grouping to the first documented disease progression or death from any cause as evaluated by the investigator according to RECIST 1.1 criteria (phase 3). up to 2 years
Secondary ORR Objective response rate (ORR) based on the RECIST 1.1 by principal investigator up to 2 years
Secondary DCR Disease control rate (DCR) based on the RECIST 1.1 by principal investigator up to 2 years
Secondary DOR Duration of response (DOR) based on the RECIST 1.1 by principal investigator up to 2 years
Secondary CBR Clinical benefit rate (CBR) based on the RECIST 1.1 by independent review committee up to 2 years
Secondary TTR Time to response (TTR) based on the RECIST 1.1 by independent review committee up to 2 years
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04263051 - Evaluation of UCPVax Plus Nivolumab as Second Line Therapy in Advanced Non Small Cell Lung Cancer Phase 2
Recruiting NCT05489731 - VIC-1911 Combined With Osimertinib for EGFR -Mutant Non-small Cell Lung Cancer Phase 1
Completed NCT01240447 - Immunotherapy With Racotumomab Versus Support Treatment in Advanced Non-small Cell Lung Cancer Patients Phase 2
Completed NCT00737867 - Vinorelbine/Gemcitabine Versus Vinorelbine/Carboplatin in Advanced Non-small Cell Lung Cancer Phase 3
Recruiting NCT05504278 - Efficacy and Safety of IBI351 in Combination With Sintilimab ± Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation Phase 1
Recruiting NCT05482568 - A Trial of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer Phase 1/Phase 2
Recruiting NCT06043973 - Almonertinib Combined With Anlotinib as First-line Treatment for Advanced Non-small Cell Lung Cance Phase 3
Completed NCT00948675 - Study of Participants With Advanced Non-Small Cell Lung Cancer Phase 3
Active, not recruiting NCT03681483 - RO5126766 for Patients With Advanced KRAS-Mutant Lung Cancer Phase 1
Recruiting NCT05099172 - First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2) Phase 1/Phase 2
Recruiting NCT02133196 - T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer Phase 2
Recruiting NCT00874328 - A Study of TS-1 Plus Irinotecan and Cisplatin (IP) for Patients With Stage IIIB/IV Non Small Cell Lung Cancer (NSCLC) Phase 1/Phase 2
Completed NCT00487669 - Phase II Study of Combination of Paclitaxel Poliglumex and Alimta for Advanced Non-small Cell Lung Cancer (NSCLC) Phase 2
Active, not recruiting NCT03516981 - A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495) Phase 2
Recruiting NCT03334864 - Observational Cohort Study of Advanced Non-small Cell Lung Cancer (CAPTRA-LUNG)
Terminated NCT00783471 - Docetaxel Intermittent-Erlotinib (Tarceva®) In Metastatic Non Small Cell Lung Cancer (NSCLC) Phase 2
Completed NCT00330746 - CALC-1 (Cetuximab in Advanced Lung Cancer): Study of 2 Methods of Combining Cetuximab and Gemcitabine in Patients With Advanced Non Small-cell Lung Cancer Phase 2
Completed NCT03117335 - Recombinant Endostatin Combined With Vinorelbine and Cisplatin in Patients With Advanced Non-small Cell Lung Cancer Phase 3
Terminated NCT00345059 - The DISTAL-2 Study: Docetaxel Alone or in Combination in Second-line Treatment of Advanced Non Small-Cell Lung Cancer Phase 3
Completed NCT01980212 - Tumor Relapsed Study of Serum Trxr Activity in Advanced Non-small Cell Lung Cancer