A Phase II Study of SKB264 + SKB118 in Nsq-NSCLC After EGFR-TKI Failure

NCT07854509 | Not Yet Recruiting Phase 2

• 1 other identifier: SKB264-II-21
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an open-label, multicenter, Phase II clinical study to evaluate the safety, tolerability, and efficacy of SKB264 in combination with SKB118 in participants with locally advanced or metastatic non-squamous NSCLC harboring EGFR-sensitizing mutations who have failed EGFR-TKI therapy. The study includes a dose escalation phase and an expansion phase.

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• The safety of SKB264 in combination with SKB118 in participants with non-squamous non-small cell lung cancer (NSCLC)

  Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (per Common Terminology Criteria for Adverse Events \[CTCAE\] v6.0)

  From enrollment to the end of treatment at 24 months

• ORR(objective response rate)

  ORR as assessed by the investigator based on RECIST v1.1

  From enrollment to the end of treatment at 24 months

Secondary Outcomes (4)

• DCR(Disease control rate )

  From enrollment to the end of treatment at 24 months

• DOR(duration of response )

  From enrollment to the end of treatment at 24 months

• PFS(progression-free survival)

  From enrollment to the end of treatment at 24 months

• OS (overall survival)

  From enrollment to the end of treatment at 24 months

Study Arms (1)

SKB264 in combination with SKB118

EXPERIMENTAL

SKB264 (4 mg/kg or other dose levels) combined with SKB118 (10 mg/kg, 20 mg/kg, or other dose levels).

Drug: SKB264+SKB118

Interventions

SKB264+SKB118 DRUG

Administered by intravenous infusion on Day 1 and Day 15 of each 28-day cycle.

SKB264 in combination with SKB118

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-squamous NSCLC that is not suitable for radical surgery and/or radical radiotherapy (regardless of whether concurrent chemotherapy has been received).
• Confirmed EGFR-sensitizing mutations.
• Participants must have failed prior EGFR-TKI therapy for locally advanced or metastatic disease.
• Participants must be confirmed during the screening period to be able to provide a tumor tissue sample. If this cannot be met, acceptability should be discussed with the medical monitor.
• At least one measurable lesion as assessed by the investigator according to RECIST v1.1.
• ECOG performance status of 0 or 1.
• Life expectancy ≥ 12 weeks.
• Adequate bone marrow, liver, kidney, and coagulation function.
• Male and female participants must agree to use highly effective contraceptive measures during the specified period of the study.

You may not qualify if:

• Histologically or cytologically confirmed small cell lung cancer, neuroendocrine carcinoma, or sarcomatoid carcinoma components, or with a squamous component of more than 10%.
• Presence of known driver gene alterations with approved targeted therapies.
• Participants with known metastases to meninges, brainstem metastases, spinal cord metastases and/or compression, active or untreated brain metastases.
• Participants with other malignant tumors within 3 years prior to the first dose.
• Presence of uncontrolled, or symptomatic, or recurrent pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
• History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid therapy, current ILD or non-infectious pneumonia.
• Presence of other moderate to severe lung disorders that may interfere with the detection or management of drug-related pulmonary toxicity and severely affect respiratory function.
• Risk of developing esophago-tracheal fistula or esophago-pleural fistula, or tumor invasion or compression of surrounding vital organs and major blood vessels.
• History of hemorrhagic diathesis or coagulopathy and/or clinically significant bleeding symptoms or risks.
• Previous or concurrent gastrointestinal diseases, surgery, and wound healing complications.
• Serious infection within 4 weeks before the first dose, active infection requiring systemic anti-infective therapy within 2 weeks before the first dose.
• Presence of active hepatitis B or hepatitis C or co-infection with HBV and HCV.
• Positive human immunodeficiency virus (HIV) test or known history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
• Known active tuberculosis.
• Known history of allogeneic organ transplant or hematopoietic stem cell transplant.

Sponsors & Collaborators

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

Central Study Contacts

Xiaoping Jin, PhD

CONTACT

028-67255495; jinxp@kelun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2029
• Last Updated: October 2, 2026

Record last verified: 2026-09