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Small Cell Lung CarcinomaPhase 2PAVENCT03568097

Immunotherapy in Combination With Chemotherapy in Small-cell Lung Cancer

A Phase 2 study testing Avelumab in people with Small Cell Lung Carcinoma, run by Hellenic Cooperative Oncology Group at 6 sites in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Carcinoma
What is being tested?
Avelumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
6 sitesGreece
Study dates
16 Sep 2018to 15 Apr 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Greece6 sites

  • Henry Dunant Hospital Center

    Athens, 115 26

  • Alexandra Hospital

    Athens, 11528

  • Attikon University Hospital

    Chaïdári, Athens, 12462

  • Agii Anargiri Cancer Hospital

    Nea Kifissia, Athens, 14564

  • Metropolitan Hospital

    Neo Faliro, Athens, 18547

  • Patra University Hospital

    Rio, Patra, 26504

Other trials in Greece

About this study

Official title: Phased Avelumab Combined With Chemotherapy as First-line Treatment for Patients With Advanced Small-cell Lung Cancer (SCLC)

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.

Read the detailed description

Advanced small cell lung cancer (SCLC) remains a disease with dismal prognosis and new therapeutics are urgently needed. SCLC is notably chemosensitive and first-line chemotherapy with platinum analogs and etoposide is associated with high rates of initial objective responses that unfortunately do not last long.

The primary endpoint for study design is 1-year PFS rate, where according to RECIST v1.1 PFS is determined as the time from the date of study entry to the date of progression, death from any cause or date of last contact.Secondary End Point is the evaluation of efficacy of the study treatment in terms of Overall Survival (OS), Best Overall Response (BOR), Objective Response Rate (ORR) and Duration of Response (DOR).

Evaluation of the safety of the study treatment by assessing Treatment-Emergent Adverse Events (TEAEs).

Evaluation of the Quality of Life of patients receiving the study the study treatment. Evaluation of potential biomarkers on fresh or archival sample,of formalin-fixed paraffin embedded tumor tissue block or a minimum of 10 unstained tumor tissue sections. Moreover 10 ml of EDTA-stored blood sample will be collected as well.

Being tested
Avelumab
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AvelumabDrug

    Also called Bavencio

    10 mg/kg will be given as intravenous infusion (IV) every two weeks (q 2 weeks) until disease progression.

Study groups in NCT03568097
Study groupRoleWhat they receive
Avelumab + Standard 1st line ChemotherapyExperimentalAdministration of cisplatin or carboplatin + etoposide every 3 weeks with phased avelumab administered every 2 weeks until disease progression.
Receives: Drug: Avelumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1- year Progression Free Survival (PFS) Rate

    Efficacy of treatment for 1- year PFS according to RECIST v1.1

    Measured: Time from inclusion in the trial up to 12 months

Secondary outcomes (9)

  1. Overall Survival Time (OS)

    Measured: Time from inclusion in the trial until the date of death due to any cause, up to 30 months.

  2. Best Overall Response (BOR).

    Best Overall Response (BOR) according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1). Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Stable disease (SD)=Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR.

    Measured: Time from inclusion in the trial up to 30 months.

  3. Objective Response Rate (ORR).

    Proportion of patients with CR or PR as the best overall response according to RECIST 1.1.

    Measured: Time from inclusion in the trial up to 30 months.

  4. Duration of Response (DOR) according to RECIST Version 1.1

    DOR will be determined according to RECIST 1.1, defined for each subject with a confirmed response as the time from the date of the first assessment demonstrating a CR or PR to date of the first assessment demonstrating PD or death from any cause within 12 weeks after the last tumor assessment, whichever occurs first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Stable disease (SD)=Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD is defined as at least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

    Measured: Time from inclusion in the trial up to 30 months.

  5. Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03

    TEAEs will be defined as the adverse events (AEs) that occur between first dose of study drug administration and 90 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state.

    Measured: From the first dose of study drug treatment up to 90 days after the last dose of study drug administration

  6. Change from baseline in European Quality Of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire

    The EQ-5D-5L Health Outcome Questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles. These profiles were converted to a continuous single index score using a one to one matching. The lowest possible score is -0.59 (unable to walk, unable to self-care, unable to do usual activities, extreme pain or discomfort, extreme anxiety or depression) and the highest is 1.00 (no problems in all 5 dimensions).

    Measured: On Day 1 every 21 days for 18 weeks then monthly up to 30 months.

  7. Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status

    EORTC QLQ-C30 is a 30-question tool used to assess the overall quality of life (QoL) in cancer subjects. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact. The EORTC QLQ-C30 GHS/QoL score ranges from 0 to 100; High score indicates better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL.

    Measured: On Day 1 every 21 days for 18 weeks then monthly up to 30 months.

  8. Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)

    EORTC QLQ-LC13 consists of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprises 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, neuropathy, alopecia, and medicine for pain). Score range: 0 (no burden of symptom domain or single symptom item) to 100 (highest burden of symptoms for symptom domains and single items).

    Measured: On Day 1 every 21 days for 18 weeks then monthly up to 30 months.

  9. Translational research

    PD-L1 expression by immunohistochemistry on available tumour tissue collected from this study.

    Measured: At baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2018
  2. Study start16 Sep 2018
  3. Primary completion15 Sep 2023
  4. Study completion15 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03568097
Sponsor's protocol ID
HE1/17
Other IDs
2017-004784-12, 2017
Acronym
PAVE
Status last verified
Oct 2026
First submitted
30 May 2018
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Avelumab in people with Small Cell Lung Carcinoma, run by Hellenic Cooperative Oncology Group at 6 sites in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1- year Progression Free Survival (PFS) Rate (time frame: Time from inclusion in the trial up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03568097.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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