A Study of DXC006 With Immune Checkpoint Inhibitors or Platinum for Small Cell Lung CancerInhibit… (NCT07559929) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Study of DXC006 With Immune Checkpoint Inhibitors or Platinum for Small Cell Lung CancerInhibitors or Platinum-Based Agents for Small Cell Lung Cancer.
China200 participantsStarted 2026-06-01
Plain-language summary
This is a Phase Ib/II, open-label clinical study designed to evaluate the safety, tolerability, preliminary anti-tumor activity, recommended Phase 2 dose (RP2D), pharmacokinetic (PK) characteristics, and immunogenicity of DXC006 in combination with an immune checkpoint inhibitor (ICI) or platinum-based chemotherapy in patients with small cell lung cancer (SCLC).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Voluntarily signed informed consent and willingness to comply with the protocol requirements.
✓. Male or female.
✓. Age ≥18 years and ≤75 years.
✓. Life expectancy ≥3 months.
✓. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
✓. Histologically or cytologically confirmed small cell lung cancer (SCLC).
✓. Toxicity from prior anti-tumor therapy has resolved to ≤ Grade 1 as defined by NCI-CTCAE version 6.0 (except alopecia); peripheral neuropathy must have completely resolved.
✓. Adequate hepatic, renal, coagulation, and cardiac function.
Exclusion criteria
✕. Histologically or cytologically confirmed combined SCLC, NSCLC, sarcomatoid carcinoma, or large cell neuroendocrine carcinoma.
✕. Within 14 days prior to the first dose: underwent plasmapheresis; received systemic corticosteroid therapy at a daily dose \>10 mg prednisone or equivalent (or equivalent anti-inflammatory activity) for more than 3 consecutive days (short-term use for prevention of contrast media allergy is permitted).
✕. Prior allogeneic hematopoietic stem cell transplantation (HSCT) or history of solid organ transplantation.
✕. Prior treatment with CD56-targeted therapy.
What they're measuring
1
Progression Free Survival (PFS)
Timeframe: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 year.
2
6-month progression-free survival rate
Timeframe: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.
3
Recommended Phase 2 Dose (RP2D)
Timeframe: Final RP2D confirmation upon completion of the Phase Ib (up to 12 months).
4
Measurement of objective response rate (ORR) per RECIST 1.1
Timeframe: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 year.
5
Measurement of disease control rate (DCR)
Timeframe: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 year.
6
Incidence of Adverse Events (AEs)
Timeframe: After first infusion of study drug, through study completion an average of 2 year.
✕. Symptomatic brain metastases or leptomeningeal metastases.
✕. History of severe or life-threatening immune-related adverse events or infusion-related reactions (including permanent discontinuation of immuno-oncology therapy due to intolerance).
✕. Active autoimmune disease or immunodeficiency, or a history of such conditions.