Limited-stage SCLC MedDRA version: 16.1 Level: PT Classification code 10041069 Term: Small cell lung cancer limited stage System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Yervoy
Product Name: Ipilimumab
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: IPILIMUMAB
CAS Number: 0477202-00-9
Concentration unit: mg/ml milligram(s)/m
Sponsors
ETOP (European Thoracic Oncology Platform)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For enrolment: - Histologically or cytologically confirmed small cell lung cancer - Untreated limited stage disease (LD) as defined by stage I-IIIB based on 7th TNM classification (IASLC classification for SCLC proposal). M0 proven by • Whole body FDG-PET CT including a contrast-enhanced CT of thorax and upper abdomen (incl. liver, kidney, adrenals); OR contrast-enhanced CT of thorax and upper abdomen (incl. liver, kidney, adrenals) and bone scan; • brain MRI. within 28 days before start of cycle 1. - Age = 18 years - ECOG performance status 0-1 - Adequate haematological function: haemoglobin > 9 g/dL neutrophils count >1.5×109/L platelet count > 100 × 109/L - Adequate liver function: Total bilirubin 40% predicted value and DLCO > 40% predicted value. - Patient capable of proper therapeutic compliance, and accessible for correct follow-up. - Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 7 days before beginning treatment. - All sexually active men and women of childbearing potential must use an effective contraceptive method (two barrier methods or a barrier method plus a hormonal method) during the study treatment and for a period of at least 12 months following the last administration of trial drugs. - Measurable or evaluable disease (according to RECIST 1.1 criteria). Not eligible: patients with only one measurable or evaluable tumour lesion which was resected or irradiated prior to enrolment. - Written Informed Consent (IC) must be signed and dated by the patient and the investigator prior to any trial-related intervention for a) Chemo-radiotherapy treatment and PCI, and subsequent randomisation b) Blood and tissue submission for translational research For randomization: - Chemo-radiotherapy completed per protocol: 4 cycles of chemotherapy, =85% of PTV of thoracic radiotherapy, as well as completed, mandatory PCI - non-PD after chemo-radiotherapy and PCI - ECOG performance status 0-2 - Recovery of all adverse events to a grade =1, except for fatigue, appetite, oesophagitis and renal impairment (where =2 is allowed) and alopecia (any grade) - Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 7 days before beginning consolidation treatment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 130 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 130
Exclusion criteria
Exclusion criteria: For enrolment: - Patient with mixed small-cell and non-small-cell histologic features - Patient with pleural or pericardial effusions proven to be malignant - Patients who have had in the past 5 years any previous or concomitant malignancy EXCEPT adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, in situ ductal carcinoma of the breast. - Patients with other serious diseases or clinical conditions, including but not limited to uncontrolled active infection and any other serious underlying medical processes that could affect the patient’s capacity to participate in the study. - Ongoing clinically serious infections requiring systemic antibiotic or antiviral, antimicrobial, antifungal therapy. - Known or suspected hypersensitivity to ipilimumab or any of its excipients. - Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results. - Documented history of severe autoimmune or immune mediated symptomatic disease that required prolonged (more than 2 months) systemic immunosuppressive (ie steroids) treatment, such as but not limited to ulcerative colitis and Crohn´s disease, rheumathoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus, or autoimmune vasculitis (eg, Wegener’s granulomatosis). - Interstitial lung disease or pulmonary fibrosis - Women who are pregnant or in the period of lactation. - Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study. - Patients with any concurrent anticancer systemic therapy. - HIV, active Hepatitis B or Hepatitis C infection - Previous radiotherapy to the thorax (prior to inclusion), including RT for breast cancer - Planned radiotherapy to lung of mean dose > 20 Gy or V20 > 35 % - Patients who received treatment with an investigational drug agent during the 3 weeks before enrolment in the study. - Prior chemotherapy or radiotherapy for SCLC For randomization: - Less than 4 cycles of chemotherapy administered, less than 85% PTV of thoracic radiotherapy delivered, or PCI not completed - Progressive disease after chemo-radiotherapy and PCI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether patients treated with chemo-radiotherapy and prophylactic cranial irradiation followed by ipilimumab consolidation have a better overall survival compared to patients treated with chemo-radiotherapy and prophylactic cranial irradiation without ipilimumab consolidation.;Secondary Objective: - To evaluate secondary measures of clinical efficacy including progression free survival (PFS), objective response rate (ORR) and time to treatment failure. - To assess the safety and the tolerability of the treatment in both arms. ;Primary end point(s): Overall survival ;Timepoint(s) of evaluation of this end point: Time from the date of randomisation until death from any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Progression-free survival by RECIST 1.1 - Objective response determined by RECIST 1.1 - Time to treatment failure - Adverse events graded according to CTCAE V4.0 ;Timepoint(s) of evaluation of this end point: - PFS: time from the date of randomisation until documented progression or death, if progression is not documented. - ORR: across all assessment time-points during the period from randomisation to termination of trial treatment. Objective response to chemo-radiotherapy determined by tumour assessment around week 15 - Time to treatment failure: from the date of randomisation to discontinuation of treatment for any reason - AEs: during complete trial duration | — |
Countries
Belgium, France, Germany, Netherlands, Poland, Spain, Switzerland, United Kingdom
Contacts
Public ContactETOP Coordinating Office
ETOP
Outcome results
None listed