SKB264+SKB118 / Nsclc · Phase 2 Trial

SKB264 in Combination With SKB118 for Non-Small Cell Lung Cancer

ClinicalTrials.gov · August 12, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registered, ongoing Phase 2 study of a novel combination (SKB264 + SKB118) in non-small cell lung cancer. The trial is actively recruiting and has not yet reported results; no efficacy or safety data are available in this registry record.

What was studied

Phase 2, Interventional, Single Group, Open label, Treatment purpose. NSCLC; age from 18 Years; to 75 Years. Intervention: SKB264 in combination with SKB118. n = 206. 2 sites: China.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a registry record for an ongoing Phase 2 trial with no results posted; it describes planned enrollment and design only, not efficacy or safety outcomes.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment (assessed at From enrollment to the end of treatment at 24 months); ORR(objective response rate) (assessed at From enrollment to the end of treatment at 24 months)

DesignPhase 2, Interventional, Single Group, Open label, Treatment purpose

PopulationNSCLC; age from 18 Years; to 75 Years

Sample size206

InterventionSKB264 in combination with SKB118

Setting2 sites: China

Reported figures

Quoted from the source exactly as published.

Estimated enrollment206

PhasePHASE 2

Primary outcome 1Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment, from enrollment to 24 months

Primary outcome 2ORR (objective response rate), from enrollment to 24 months

Caveats

No results are posted in this registry record; outcomes cannot be assessed.
Study is still recruiting; enrollment may change and final analysis is not complete.
Open-label design; no blinding or control arm described.
No baseline characteristics, eligibility criteria, dosing details, or follow-up protocol provided in this registration.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Open-label, multi-centre Phase 2 with dose escalation and expansion phases.

Directness

strong

Directly addresses NSCLC patients; combination drug therapy in active clinical development.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

limited

Open-label design carries risk of performance and detection bias; blinding not employed.

Sample adequacy

moderate

206 estimated participants is typical for Phase 2; final enrollment and analysis status unknown.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07697586). This is a study registration, not published results. Lead sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 206 participants (ESTIMATED). Conditions: NSCLC. Interventions: DRUG: SKB264+SKB118. Primary outcome measures: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment , From enrollment to the end of treatment at 24 months; ORR(objective response rate) , From enrollment to the end of treatment at 24 months. Brief summary: This is an open-label, multi-center, Phase II clinical study to evaluate the safety, tolerability, and efficacy of SKB264 in combination with SKB118 in participants with NSCLC. The study includes a dose escalation phase and an expansion phase.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

SKB264+SKB118NsclcSichuan Kelun-Biotech Biopharmaceutical Co.NCT07697586