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IFCT-1802 SAVIMMUNE: Immunotherapy in Patient With Poor General Condition
EU CTIS ID: 2024-515943-44-00
What this study is testing
IFCT-1802 SAVIMMUNE phase 2 trial aims to study the safety and efficacy of a first-line therapy with anti-PD-L1 monoclonal DURVALUMAB antibody, in a subset of patient with PS 2-3, but highly PD-L1 expressing tumors, who are usually excluded from clinical trials, and for whom, thus, there is no recognized indication for immunotherapy. The hypothesis of this trial is that in such selected patients, tolerance of durvalumab would be acceptable, while its efficacy would rapidly improve general condition, resulting in significantly long survivals.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care. Subjects must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.
- Limited field of radiation for palliation within 2 weeks of the first dose of durvalumab is allowed, provided the lung is not in the radiation field and irradiated lesion(s) cannot be used as target lesions.
- Age 18-75 years.
- Measurable tumor disease by CT per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The radiological assessment has to be done within the timelines indicated.
- Life expectancy > 8 weeks according to the investigator opinion.
- Adequate biological functions: neutrophils ≥ 1500/mm3 ; platelets ≥ 75 000/mm3 ; Hemoglobin ≥ 9 g/dL ; Creatinine Clearance > 40 mL/min , AST and ALT ≤ 2,5 ULN unless liver metastases are present, AST and ALT ≤ 5 x ULN, serum bilirubine ≤ 1.5 x ULN except for patients with proved, Gilbert syndrome (≤ 5 x ULN) or patients with hepatic metastases (≤ 3 x ULN).
You likely can't join if
- Pure or combined SCLC.
- Pre-existing interstitial lung.
- History of another primary malignancy except for : • Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of IP and of low potential risk for recurrence • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease • Adequately treated carcinoma in situ without evidence of residual disease Patients with a prostate adenocarcinoma history within the previous 5 years could be included in case of localized prostate cancer.
- Living attenuated vaccine received within the 30 previous days.
- Received any other experimental treatment or participation to any other therapeutic clinical trial.
- Known allergy or hypersensitivity to any of the study drug or any of the study drug excipients.
See the full eligibility criteria
Who can join
- Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care. Subjects must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.
- Limited field of radiation for palliation within 2 weeks of the first dose of durvalumab is allowed, provided the lung is not in the radiation field and irradiated lesion(s) cannot be used as target lesions.
- Age 18-75 years.
- Measurable tumor disease by CT per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The radiological assessment has to be done within the timelines indicated.
- Life expectancy > 8 weeks according to the investigator opinion.
- Adequate biological functions: neutrophils ≥ 1500/mm3 ; platelets ≥ 75 000/mm3 ; Hemoglobin ≥ 9 g/dL ; Creatinine Clearance > 40 mL/min , AST and ALT ≤ 2,5 ULN unless liver metastases are present, AST and ALT ≤ 5 x ULN, serum bilirubine ≤ 1.5 x ULN except for patients with proved, Gilbert syndrome (≤ 5 x ULN) or patients with hepatic metastases (≤ 3 x ULN).
- Other investigations detailed in Section 5 must have been performed within the timelines indicated.
- Protocol treatment is to begin within 7 days of patient inclusion.
- Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: - Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy). - Women ≥50 years of age would be considered post-menopausal if they have been aamenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
- Females of childbearing potential who are sexually active with a nonsterilized male partner or men who are sexually active with women of childbearing potential must use a highly effective method of contraception prior the first dose of investigational product, and must agree to continue using such precautions for 90 days after the final dose of investigational product. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.
- Histologically or cytologically-proven NSCLC (squamous or non-squamous). If the diagnosis is cytologically-proven, sufficient material is necessary with at least 100 tumor cells evaluated for PD-L1 IHC.
- PD-L1 expression ≥25% of tumor cells as assessed by the local pathology laboratory using protocols validated.
- Available tumor samples for centralized PD-L1 immunohistochemistry analysis.
- No EGFR mutation and no ALK gene rearrangement.
- Stage IV (8th classification TNM) M1a or M1b or M1c.
- ECOG PS= 2 or3 despite optimal symptomatic treatment.
- Body weight >30kg
- No prior systemic anticancer therapy (chemotherapy, immunotherapy including durvalumab, or EGFR or ALK inhibitors) given as primary therapy for advanced or metastatic disease. Neoadjuvant or adjuvant chemotherapy is not considered as chemotherapy for advanced or metastatic disease.
What rules you out
- Pure or combined SCLC.
- Pre-existing interstitial lung.
- History of another primary malignancy except for : • Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of IP and of low potential risk for recurrence • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease • Adequately treated carcinoma in situ without evidence of residual disease Patients with a prostate adenocarcinoma history within the previous 5 years could be included in case of localized prostate cancer.
- Living attenuated vaccine received within the 30 previous days.
- Received any other experimental treatment or participation to any other therapeutic clinical trial.
- Known allergy or hypersensitivity to any of the study drug or any of the study drug excipients.
- Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
- Major surgical procedure within 28 days prior to the first dose of IP or planned surgical procedure during treatment.
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
- Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen (HBsAg) result) and hepatitis C. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. History of active tuberculosis or evident primo-infection for which there is no record or evidence of an active anti-tuberculous treatment (please consult IFCT in case of doubt).
- Patient with human immunodeficiency vurys (positive HIV ½ antibodies)
- Known HER2, B-Raf, activating tumor mutations, or exon 14 c-MET splice mutations, or known ROS1 gene rearrangement.
- Any condition that, in the opinion of investigator, could compromise the adherence to treatment and follow-up.
- Mental illness or psychological condition, which in the opinion of investigator could compromise the expression of the informed consent.
- No public health insurance.
- Asymptomatic or symptomatic brain metastasis.
- Carcinomatous meningitis.
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion: - Patients with vitiligo or alopecia - Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement - Any chronic skin condition that does not require systemic therapy - Patients without active disease in the last 5 years may be included but only after consultation with IFCT - Patients with celiac disease controlled by diet alone
- Immunosuppressive treatment including systemic treatment with corticosteroids with greater dose than 10 mg prednisone equivalent daily, within 15 days before enrollment. Inhaled, nasal or topic corticosteroids are allowed.
- History of allogenic organ transplantation.
- Stage 4 (very severe, FEV1<30% predicted) chronic obstructive pulmonary disease (COPD) according to GOLD classification.
- NYHA (New York Heart Association) class 4 chronic heart failure
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.