Continued PD-L1 Inhibition With Atezolizumab With Rechallenge Chemotherapy in Patients With Sensitive Relapse SCLC Progressing on First-line Platinum-etoposide Chemotherapy and a PD-L1 Inhibitor: CARRY-ON Study-GOIRC-01-2023

Status: Recruiting
Location: See all (25) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosis of small-cell lung cancer (SCLC) (according to WHO classification 2015) confirmed at pathology (histology or cytology).

• Male or female and ≥ 18 years of age.

• Life expectancy ≥ 12 weeks.

• 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.

• No previous radiotherapy on the only one site disease progression, unless that site had subsequent evidence of progressive disease.

• Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2.

• 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)

• 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.

• 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.

⁃ 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.

⁃ 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.

⁃ Recovered (i.e., ≤ grade 1 toxicity) from effects of prior anticancer therapy, except alopecia.

⁃ 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

⁃ Ability to comply with protocol requirements.

⁃ 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.

Locations
Other Locations
Italy
Centro di Riferimento Oncologico di Aviano (CRO) IRCCS
NOT_YET_RECRUITING
Aviano (pn)
IRCCS Istituto Tumori Giovanni Paolo II
NOT_YET_RECRUITING
Bari
IRCCS Azienda Ospedaliero_Universitaria di Bologna
RECRUITING
Bologna
UOC Medicina Oncologica
NOT_YET_RECRUITING
Carpi
ASST Cremona
NOT_YET_RECRUITING
Cremona
Azienda Ospedaliera S. Croce e Carle di Cuneo
NOT_YET_RECRUITING
Cuneo
AOU Careggi
NOT_YET_RECRUITING
Florence
Azienda USL Toscana nord-ovest Ospedale Versilia
RECRUITING
Lido Di Camaiore
Azienda USL Toscana Nord Ovest - Ospedale San Luca
NOT_YET_RECRUITING
Lucca
Istituto Scientifico Romagnolo per lo studio e la cura dei Tumori (IRST) Dino Amadori
NOT_YET_RECRUITING
Meldola (fc)
IRCCS Ospedale San Raffaele
NOT_YET_RECRUITING
Milan
AOU Policlinico di Modena
NOT_YET_RECRUITING
Modena
ASST San Gerardo dei Tintori Foundation
NOT_YET_RECRUITING
Monza
AORN A. Cardarelli
NOT_YET_RECRUITING
Napoli
AOU San Luigi Gonzaga
NOT_YET_RECRUITING
Orbassano (to)
Istituto Oncologico Veneto
NOT_YET_RECRUITING
Padua
UOC di Oncologia Medica
NOT_YET_RECRUITING
Parma
Azienda Ospedaliera Santa Maria della Misericordia
NOT_YET_RECRUITING
Perugia
Azienda USL IRCCS di Reggio Emilia
NOT_YET_RECRUITING
Reggio Emilia
Fondazione Policlinico Universitario A.Gemelli IRCCS - Università Cattolica del Sacro Cuore
NOT_YET_RECRUITING
Roma
Istituto Nazionale Tumori Regina Elena
NOT_YET_RECRUITING
Roma
AOU Sassari
NOT_YET_RECRUITING
Sassari
Azienda Ospedaliera Santa Maria di Terni
NOT_YET_RECRUITING
Terni
Azienda Sanitaria Universitaria Friuli Centrale - P.O. Santa Maria della Misericordia
NOT_YET_RECRUITING
Udine
AOU Integrata di Verona
NOT_YET_RECRUITING
Verona
Contact Information
Primary
Andrea Ardizzoni, MD
andrea.ardizzoni@aosp-bo.itt
0039-051-2142206
Backup
Giuseppe Lamberti, MD
giuseppe.lamberti8@unibo.it
0039-051-2143067
Time Frame
Start Date: 2025-01-24
Estimated Completion Date: 2029-06-01
Participants
Target number of participants: 142
Treatments
Experimental: Arm 1
re-challenge chemotherapy plus atezolizumab 1200 mg flat dosing
Sponsors
Collaborators: Roche Pharma AG
Leads: Gruppo Oncologico Italiano di Ricerca Clinica

This content was sourced from clinicaltrials.gov