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Atezolizumab and Rechallenge Chemotherapy in Relapsed Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC).

RecruitingPhase 2Ages 18 Years - anyAllGruppo Oncologico Italiano di Ricerca Clinica
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to learn if a combination of atezolizumab and standard chemotherapy works to treat sensitive Extensive-stage Small Cell Lung Cancer, progressing after first-line of treatment. The main questions it aims to answer are: * Does combination of atezolizumab and standard chemotherapy increase overall survival? * What medical problems do participants have when taking combination of atezolizumab and standard chemotherapy? Participants will: * take atezolizumab and standard chemotherapy every 3 weeks for 4 cycles and than atezolizumab every 3 weeks up to 18 cycles. * visit the clinic once every 3 weeks for checkups and tests * perform Radiological assessments after 6 weeks and then every 12 weeks to determine response to treatment.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Diagnosis of small-cell lung cancer (SCLC) (according to WHO classification 2015) confirmed at pathology (histology or cytology). 2. Male or female and ≥ 18 years of age. 3. Life expectancy ≥ 12 weeks. 4. Disease progression at least 60 days after the completion of first-line chemotherapy consisting of at least 4 cycles of platinum-etoposide plus either atezolizumab or durvalumab and have not received any other treatment (except for immunotherapy as maintenance treatment); the 60 day-interval is calculated from the date of the last chemotherapy administration to the date of the first radiologically documented progressive disease. 5. No previous radiotherapy on the only one site disease progression, unless that site had subsequent evidence of progressive disease. 6. Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2. 7. Patients with treated brain metastases (or untreated but asymptomatic) and off steroids or on a stable dose of steroids (≤10 mg of prednisone-equivalent) are also eligible. Radiotherapy must have been completed a minimum of 14 days prior to registration, and patients must have recovered from AEs related to radiotherapy to \< grade 1 (except alopecia) 8. For Females: must be postmenopausal (defined as occurring 12 months after last menstrual period) before the screening visit, or are surgically sterile. If they are of childbearing potential, a negative serum pregnancy test prior to study entry has to be documented; furthermore, they agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form (ICF) through 5 months after the last dose of study drug,or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. 9. For Males: even if surgically sterilized (i.e., post-vasectomy status) agree to practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of study drug, or practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. 10. Normal baseline laboratory values as specified below: * Absolute neutrophil count (ANC) ≥1500/mm3 * Platelet count ≥ 100 x 109/L (≥100,000/μL) without transfusion * Hemoglobin ≥ 90 g/L (≥ 9 g/dL); patients may be transfused to meet this criterion. * Total bilirubin \< 1.5x the institutional upper limit of normal (ULN) * Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 2.5x the institutional ULN (\< 5x if liver function test elevations are due to liver metastases) * Creatinine \< 1.5x institutional ULN or estimated creatinine clearance using the Cockcroft-Gault formula ≥ 30 mL/minute for patients with creatinine levels above institutional limits * For patients not receiving therapeutic anticoagulation: INR and aPTT ≤ 1.5 x ULN * Negative HIV test at screening {with the following exception: patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count ≥ 200/μL, and have an undetectable viral load} * Negative hepatitis B surface antigen (HBsAg) test at screening * Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening accompanied by either of the following: * Negative total hepatitis B core antibody (HBcAb) * Positive total HBcAb test followed by a negative (per local laboratory definition) hepatitis B virus (HBV) DNA testNegative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening The HCV RNA test must be performed for patients who have a positive HCV antibody test. 11. Stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections, or major surgery within 4 weeks before registration, and otherwise noted in other inclusion/exclusion criteria. 12. Recovered (i.e., ≤ grade 1 toxicity) from effects of prior anticancer therapy, except alopecia. 13. Prior radiotherapy is allowed provided that it has been completed more than 2 weeks before starting protocol treatment and patients have recovered from AEs related to radiotherapy to \< grade 1 14. Ability to comply with protocol requirements. 15. The patient or the patient's legal representative has to be able to provide written informed consent. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care. Exclusion Criteria: 1. More than 1 line of prior treatment for ES-SCLC. 2. First-line treatment without either atezolizumab or durvalumab. 3. First-line chemotherapy other than platinum-etoposide. 4. Less than 4 cycles of first-line platinum-etoposide. 5. Presence of resistant relapse (progressive disease within 60 days from the end of first-line chemotherapy) or refractory disease (progressive disease during the first 4 cycles of first-line chemoimmunotherapy). 6. Symptomatic brain metastases or spinal cord compression (CT or MRI of the head is required within 4 weeks prior to randomization)requiring immediate radiotherapy for palliation. Patients with treated brain metastases (or untreated but asymptomatic) and off steroids or on a stable dose of steroids (≤10 mg of prednisone-equivalent) are also eligible provided that all of the following criteria are met: * If treated, at least 14 days between the end of stereotactic radiotherapy or whole brain radiotherapy and initiation of study treatment and recovery from AEs related to radiotherapy to ≤ grade 1 (except alopecia), or at least 28 days between neurosurgical resection and initiation of study treatment; * Anticonvulsant therapy at a stable dose is permitted; * Metastases are limited to the c
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What it tests

  • Atezolizumab
  • Carboplatin
  • Etoposide
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Where

25 sites
Centro di Riferimento Oncologico di Aviano (CRO) IRCCS
Aviano (PN), Italy
IRCCS Istituto Tumori "Giovanni Paolo II"
Bari, Italy
IRCCS Azienda Ospedaliero_Universitaria di Bologna
Bologna, Italy
UOC Medicina Oncologica
Carpi, Italy
ASST Cremona
Cremona, Italy
Azienda Ospedaliera S. Croce e Carle di Cuneo
Cuneo, Italy
AOU Careggi
Florence, Italy
Azienda USL Toscana nord-ovest Ospedale Versilia
Lido di Camaiore, Italy

…and 17 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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