Clinical trial · Interventional
Immunotherapy in Combination With Chemotherapy in Small-cell Lung Cancer
Phased Avelumab Combined With Chemotherapy as First-line Treatment for Patients With Advanced Small-cell Lung Cancer (SCLC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
PAVE(Phased Avelumab combined with chemotherapy as first-line treatment for patients with advanced small-cell lung cancer) is a Greek, investigator- initiated, single arm open- label phase II study of Avelumab in combination with cisplatin or carboplatin/ etoposide. The study will include an initial safety run-in, open-label, singlearm part (Part 1), and the actual phase II study (Part 2). The total number of patients will not change (the safety run-in patients will be included in the final total number of participants). The safety run-in period will not alter the total study timelines, as phase II accrual will follow immediately after the safety run-in.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Carcinoma | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Avelumab | Drug | Avelumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Avelumab + Standard 1st line Chemotherapy
- description
- Administration of cisplatin or carboplatin + etoposide every 3 weeks with phased avelumab administered every 2 weeks until disease progression.
- interventionNames
- Drug: Avelumab
Primary outcomes (1)
- measure
- 1- year Progression Free Survival (PFS) Rate
- timeFrame
- Time from inclusion in the trial up to 12 months
- description
- Efficacy of treatment for 1- year PFS according to RECIST v1.1
Secondary outcomes (9)
- measure
- Overall Survival Time (OS)
- timeFrame
- Time from inclusion in the trial until the date of death due to any cause, up to 30 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed written informed consent * Male or female patients aged more than or equal to (≥) 18 years * With Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry * At least 1 measurable tumor lesion by RECIST 1.1 * With histologically confirmed metastatic (Stage IV) small cell lung cancer (SCLC) * Patients must not have received any previous systemic treatment for small cell lung cancer * Patients must have an estimated life expectancy of more than 12 weeks * Patients must have an available recently-obtained, formalin-fixed, paraffin-embedded (FFPE) tissue sample containing tumor (biopsy preferably within 6 months) or a minimum number of 10 unstained slides, suitable for PD-L1 expression assessment. Exclusion Criteria: * Patients with brain metastases are excluded, except those with brain metastases that have been treated with surgery or radiation and are clinically stable for at least 2 weeks prior to registration. * Prior therapy with any antibody or drug targeting T cell co-regulatory proteins, concurrent anticancer treatment, or immunosuppressive agents * Patients on current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)." * Known severe hypersensitivity reactions to monoclonal antibodies, history of anaphylaxis, or uncontrolled asthma, and persisting toxicity related to prior therapy of Grade \> 1 NCI-CTCAE v 4.03. * Patients with active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. * Patients with prior organ transplantation including allogenic stem-cell transplantation are excluded. * Patients with an active infection requiring systemic therapy are excluded. * Patients with known history of testing positive for HIV or known acquired immunodeficiency syndrome are excluded. * Also excluded are patients with Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive) * Vaccination within 4 weeks of the first dose of avelumab and while on trials is prohibited except for administration of inactivated vaccines. * Persisting toxicity related to prior therapy * Other severe acute or chronic medical conditions.
References
Publications (0)
Data not yet available