A Study of SKB571 Combination Therapy in Participants With Non-Small Cell Lung Cancer (NSCLC)

NCT07622186 | Not Yet Recruiting Phase 2

• 1 other identifier: SKB571-II-05
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 27

Brief Summary

This is an open-label, multicenter, phase II study. The purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of SKB571 Combination Therapy in participants with Non-Small Cell Lung Cancer (NSCLC).

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Up to approximately 36 months

Secondary Outcomes (9)

• Progression-free survival (PFS), duration of response (DOR), disease control rate (DCR), and overall survival (OS)

  Up to approximately 36 months

• Safety and tolerability

  Up to approximately 36 months

• Maximum Plasma Concentration (Cmax) of SKB571-ADC

  Up to approximately 36 months

• Immunogenicity

  Up to approximately 36 months

• Minimum Plasma Concentration(Cmin) of SKB571-ADC

  Up to approximately 36 months

Other Outcomes (1)

• Correlation between biomarkers and efficacy

  Up to approximately 36 months

Study Arms (3)

NSCLC with sensitive EGFR mutations

EXPERIMENTAL

Drug: SKB571 for injection; Drug: Osimertinib; Drug: Furmonertinib

NSCLC with EGFR wild-type

EXPERIMENTAL

Drug: SKB571 for injection; Drug: carboplatin; Drug: Cisplatin; Drug: Pembrolizumab

NSCLC with uncommon EGFR mutations

EXPERIMENTAL

Drug: SKB571 for injection; Drug: Furmonertinib; Drug: carboplatin; Drug: Cisplatin

Interventions

SKB571 for injection DRUG

Intravenous(IV) infusion(Q3W)

NSCLC with EGFR wild-type; NSCLC with sensitive EGFR mutations; NSCLC with uncommon EGFR mutations

Osimertinib DRUG

orally once daily

NSCLC with sensitive EGFR mutations

Furmonertinib DRUG

orally once daily

NSCLC with sensitive EGFR mutations; NSCLC with uncommon EGFR mutations

carboplatin DRUG

Intravenous(IV) infusion(Q3W)

NSCLC with EGFR wild-type; NSCLC with uncommon EGFR mutations

Cisplatin DRUG

Intravenous(IV) infusion(Q3W)

NSCLC with EGFR wild-type; NSCLC with uncommon EGFR mutations

Pembrolizumab DRUG

Intravenous(IV) infusion(Q3W)

NSCLC with EGFR wild-type

Eligibility Criteria

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

You may qualify if:

• Male or female, age ≥ 18 years and ≤ 75 years at the time of signing the informed consent form (ICF).
• Participants must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
• At least one measurable lesion as assessed by the investigator according to RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy ≥ 12 weeks as assessed by the investigator.
• Adequate organ and bone marrow function.
• Male and female participants must agree to use highly effective methods of contraception during the study treatment period.
• Participants must voluntarily join this study, sign the ICF, and be able to comply with the visits and related procedures specified in the protocol.

You may not qualify if:

• Participants with other malignant tumors within 3 years before the first dose of study treatment.
• Active or untreated central nervous system (CNS) metastasis.
• Current uncontrolled concomitant diseases
• Clinically severe lung damage due to complications of lung disorder
• Participants with a history of interstitial lung disease (ILD)/non-infectious pneumonitis
• A history of severe skin diseases
• Unresolved toxicity from prior anti-tumor therapy
• Serious infection within 4 weeks before the first dose of study treatment
• Known active pulmonary tuberculosis.
• Participants who have undergone major surgery or had severe trauma within 4 weeks before the first dose, or are expected to require major surgery during the study.
• Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant.
• Pregnant or breastfeeding women.
• Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.

Sponsors & Collaborators

• Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.: lead

Study Sites (27)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Xinqiao Hospital of Army Medical University

Chongqing, Chongqing Municipality, 400037, China

Location

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

Location

Dongguan People's Hospital

Dongguan, Guangdong, 523018, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Guangzhou Medical University First Affiliated Hospital

Guangzhou, Guangdong, 510120, China

Location

Guilin Medical University First Affiliated Hospital

Guilin, Guangxi, 541001, China

Location

Guangxi Medical University Affiliated Tumor Hospital

Nanning, Guangxi, 530021, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Xiangyang Central Hospital

Xiangyang, Hubei, 441021, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

Jiangxi Cancer Hospital

Nanchang, Jiangxi, 330029, China

Location

Jilin Cancer Hospital

Changchun, Jilin, 130012, China

Location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

Location

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

Location

Shanxi Cancer Hospital

Taiyuan, Shanxi, 030013, China

Location

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi’an, Shanxi, 710061, China

Location

Sichuan Cancer Hospital & Institute

Chengdu, Sichuan, 610041, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Xinjiang Medical University Affiliated Tumor Hospital

Ürümqi, Xinjiang Uygur Autonomous Region, 830011, China

Location

Yunnan Cancer Hospital

Kunming, Yunnan, 650118, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Injections; osimertinib; aflutinib; Carboplatin; Cisplatin; pembrolizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Xin Li, MD

  Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Xin Li, MD

CONTACT

86-13311373861; lixin@kelun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 3, 2026
• Study Start (Estimated): July 31, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 3, 2026

Record last verified: 2026-05

Locations

CN (27)