Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT05870319
NCT05870319Active, not recruitingPhase 3

A Randomized, Open-Label, Multicenter Phase 3 Study to Evaluate SKB264 Monotherapy Versus Pemetrexed in Combination With Platinum in Patients With Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With EGFR Mutation Who Have Failed to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Therapy

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.2 sites in 1 country376 target enrollmentStarted: June 26, 2023Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Active, not recruiting
Enrollment
376
Locations
2
Primary Endpoint
Progression-free survival (PFS)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This is a randomized, open-label, multicenter Phase 3 clinical study to evaluate SKB264 monotherapy versus pemetrexed in combination with platinum in subjects with locally advanced or metastatic non-squamous NSCLC with EGFR mutation who have failed to EGFR-TKI therapy.

Detailed Description

This is a randomized, open-label, multicenter Phase 3 clinical study to evaluate SKB264 monotherapy versus pemetrexed in combination with platinum in subjects with locally advanced or metastatic non-squamous NSCLC with EGFR mutation who have failed to EGFR-TKI therapy. The primary objective is to compare the efficacy and safety of SKB264 monotherapy versus pemetrexed in combination with platinum in patients with locally advanced or metastatic non-squamous NSCLC with EGFR mutation who have failed to EGFR-TKI therapy.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Males or females aged ≥18 to ≤75 years at the time of signing the ICF;
  • •Histologically or cytologically confirmed non-squamous NSCLC and locally advanced (stage IIIB/IIIC) or metastatic (Stage IV) non-squamous NSCLC not amenable to radical surgery and/or radical concurrent/sequential chemoradiotherapy;
  • •EGFR-sensitive mutations;
  • •Failure of prior EGFR-TKI therapy;
  • •At least one measurable target lesion per RECIST 1.1 as assessed by the investigator;
  • •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  • •Expected survival ≥12 weeks;
  • •Adequate organ and bone marrow function;
  • •Female subjects of childbearing potential and male subjects with partners of childbearing potential who use effective medical contraception from the time of signing the informed consent form until 6 months after the last dose;
  • •Subjects voluntarily participate in the study, sign the ICF, and will be able to comply with the protocol-specified visits and relevant procedures

Exclusion Criteria

  • •Histologically or cytologically confirmed presence of small cell lung cancer, neuroendocrine carcinoma, and carcinosarcoma components or squamous cell carcinoma components of more than 10%;
  • •Other malignancies within 3 years prior to the first dose;
  • •History of (noninfectious) interstitial lung disease (ILD)/noninfectious pneumonitis requiring steroid therapy and current ILD/noninfectious pneumonitis;
  • •Subjects with active chronic inflammatory bowel disease, GI tract obstruction, severe ulcers, perforation gastrointestinal, abdominal abscess, or acute GI tract bleed;
  • •Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1 (per NCI CTCAE 5.0) or to the level specified in the eligibility criteria;
  • •Subjects with human immunodeficiency virus (HIV) test positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection;
  • •Prior TROP2-targeted therapy;
  • •Prior treatment with any drug therapy targeting topoisomerase I inhibitor, including antibody-drug conjugates (ADCs);
  • •Major surgery within 4 weeks prior to the first dose or expected to require major surgery during the study;
  • •Subjects who have received live vaccines within 30 days prior to the first dose, or are scheduled to receive live vaccines during the study;
  • •Pregnant or lactating women;

Arms & Interventions

SKB264 by IV infusion on Days 1 and 15 of each 4-week cycle;

Experimental

Intervention: SKB264 (Drug)

pemetrexed+ carboplatin or on Day 1 of each 3-week cycle, with 4 cycles chemo

Active Comparator

Intervention: Pemetrexed (Drug)

pemetrexed+ carboplatin or on Day 1 of each 3-week cycle, with 4 cycles chemo

Active Comparator

Intervention: Carboplatin (Drug)

pemetrexed+ carboplatin or on Day 1 of each 3-week cycle, with 4 cycles chemo

Active Comparator

Intervention: Cisplatin (Drug)

Outcomes

Primary Outcomes

Progression-free survival (PFS)

Time Frame: From baseline until disease progression, death, or other protocol defined reason,up to approximately 36 months

PFS assessed by BIRC per RECIST 1.1

Secondary Outcomes

  • Overall survival (OS)(From the date of randomization to the date of death due to any cause. Up to 2 years.)
  • Progression-free survival (PFS)(From baseline until disease progression, death, or other protocol defined reason,up to approximately 36 months)
  • Duration of response(DOR)(From baseline until disease progression, death, or other protocol defined reason, up to approximately 36 months)
  • Time to response(TTR)(Up to 2 years)
  • Objective response rate(ORR)(Up to 2 years)
  • Disease control rate(DCR)(Up to 2 years)
  • AEs and SAEs(AEs should be observed and recorded from signing the ICF until 30 days after the last dose. AEs occurring 30 days after the last dose are not required to be actively collected by the investigator.)
  • Mean change from baseline in the European Organisation for Research and Treatment of Cancer (EORTC) complementary 13-item quality-of-life questionnaire - lung cancer symptoms questionnaire (QLQ-LC13)(Up to 2 years)
  • Mean change from baseline in the European Organisation for Research and Treatment of Cancer (EORTC) 30-item core quality-of-life questionnaire (QLQ-C30）(Up to 2 years)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

Similar Trials

Active, not recruiting
Phase 3
Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic LeukemiaUntreated Chronic Lymphocytic Leukemia
NCT04075292AstraZeneca155
Completed
Phase 3
Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic ChemotherapyNeutropeniaBreast Cancer
NCT03252431EVIVE Biotechnology393
Recruiting
Phase 3
A Study of SKLB1028 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory (R/R) AML With FLT3-MutatedAcute Myeloid Leukemia (AML)
NCT04716114CSPC ZhongQi Pharmaceutical Technology Co., Ltd.315
Recruiting
Phase 3
Tislelizumab in Combination With GP or TPC Regimen for the Treatment of Nasopharyngeal Carcinoma With Bone Metastasis.Nasopharyngeal Carcinoma
NCT06383780XIANG YANQUN90
Recruiting
Phase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)TNBC - Triple-Negative Breast Cancer
NCT05999149Fudan University424