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New treatment option for Metastatic NSCLC
Official title De-escalation Immunotherapy mAintenance Duration Trial for Stage IV Lung Cancer Patients With Disease Control After Chemo-immunotherapy Induction
ClinicalTrials.gov ID: NCT05255302
What this study is testing
What is Pembrolizumab before randomization?
Pembrolizumab before randomization is an investigational medicine, being studied as a potential treatment for metastatic nsclc.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Immunotherapeutic approaches recently have demonstrated clinical efficacy in several cancer types, including melanoma and NSCLC. As a matter of fact, first registration trials of immune-checkpoints inhibitors (ICI) in second-line settings (pembrolizumab as well as nivolumab or atezolizumab) had stated that ICI could be continued until disease progression or not tolerable toxicity, up to 5 years.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 74
You may be able to join if
- Signed Written Informed Consent:
- people must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This...
- people must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.
- Patients with histologically confirmed metastatic NSCLC (Stage IV accordingly to 8th classification TNM, UICC 2015). A cytologically-proven NSCLC is...
- PD-L1 tumor content as assessed locally by the investigator center.
You likely can't join if
- Small cell lung cancer or tumors with mixed histology including a SCLC component. Note : Sarcomatoid histology is allowed. Neuro-endocrine large cell...
- Known EGFR activating tumor mutation (deletion LREA in exon 19, L858R ou L861X mutations in exon 21, G719A/S mutation in exon 18, exon 20 insertion)...
- Known ALK, ROS1, Ret, NTRK, NRG1 gene rearrangement as assessed by immunohistochemistry, FISH or NGS (ADN or ARN) sequencing by local genetics and/or...
- Previous or active cancer within the previous 3 years (except for treated carcinoma in situ of the cervix, or basal cell skin cancer treated or not)...
- Superior vena cava syndrome persisting despite VCS stenting.
- Radiotherapy needed at initiation of tumour treatment, except bone palliative radiotherapy on a painful or compressive metastasis, respecting 1 week...
See the full eligibility criteria
Who can join
- Signed Written Informed Consent:
- people 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...
- people must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.
- Patients with histologically confirmed metastatic NSCLC (Stage IV accordingly to 8th classification TNM, UICC 2015). A cytologically-proven NSCLC is allowed if a cytoblock has been prepared.
- PD-L1 tumor content as assessed locally by the investigator center.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Weight loss\< 10% within 3 months of study entry.
- No prior systemic anticancer therapy (including EGFR or ALK inhibitors) given as primary therapy for advanced or metastatic disease.
- Age≥ 18 years, \<75 years
- Life expectancy \> 3 months
- Measurable tumor disease by CT or MRI per RECIST 1.1 criteria
- The Investigator must confirm prior to enrolment that the patient has adequate tumor tissue available. Tumor biopsy should be exploitable for molecular analysis. If archival tissue is either insufficient or unavailable...
- Adequate biological functions: Creatinine Clearance ≥ 45 mL/min (Cockcroft or MDRD or CKD-epi); neutrophils≥ 1500/mm3 ; platelets ≥100 000/mm3 ; Hemoglobin≥ 9g/dL ; AST and ALT\< 3x ULN, total bilirubin \< 2xULN...
- Women of childbearing potential (WOCBP) and sexually active should use an efficacious contraception method within the 28 days preceding the first dose and during the 6 months following the last dose of treatment. Women...
- For Male people who are sexually active with WOCBP, an efficacious contraception method should be used during the treatment and during the 6 months following the last dose.
- Patient has national health insurance coverage.
What rules you out
- Small cell lung cancer or tumors with mixed histology including a SCLC component. Note : Sarcomatoid histology is allowed. Neuro-endocrine large cell lung cancer with molecular features of small-cell lung cancer (i.e...
- Known EGFR activating tumor mutation (deletion LREA in exon 19, L858R ou L861X mutations in exon 21, G719A/S mutation in exon 18, exon 20 insertion) or HER2 exon 20 insertion (either tissue or plasma cfDNA mutation).
- Known ALK, ROS1, Ret, NTRK, NRG1 gene rearrangement as assessed by immunohistochemistry, FISH or NGS (ADN or ARN) sequencing by local genetics and/or pathology laboratory.
- Previous or active cancer within the previous 3 years (except for treated carcinoma in situ of the cervix, or basal cell skin cancer treated or not). Patients with a prostate adenocarcinoma history within the previous 3...
- Superior vena cava syndrome persisting despite VCS stenting.
- Radiotherapy needed at initiation of tumour treatment, except bone palliative radiotherapy on a painful or compressive metastasis, respecting 1 week delay between the end of radiotherapy and the beginning of treatment
- Symptomatic untreated brain metastasis (without previous whole brain radiotherapy or stereotactic ablative brain radiotherapy or without surgical resection). At least 2 weeks delay between the end of radiotherapy and...
- History of previous primary immunodeficiency, organ transplantation needing an immunosuppressive treatment, any immunosuppressive drug within 28 days before randomization date, or history of severe toxicity (grade 3/4)...
- Systemic treatment with corticosteroids with greater dose than 10 mg prednisone equivalent daily, within 14 days before initiation of the immunotherapy induction. Inhaled, nasal or topic corticosteroids are allowed.
- History of active autoimmune disease including but not limited to rheumatoid polyarthritis, myasthenia, autoimmune hepatitis, systemic Lupus, Wegener's granulomatosis, vascular thrombosis associated with...
- Active inflammatory intestinal disease (Crohn disease, Hemorrhagic recto-colitis, coeliac disease) or any serious chronic intestinal disease with uncontrolled diarrhea.
- Active uncontrolled infection including tuberculosis, known acute viral hepatitis B and C according to serological tests. Patients with serological sequelae of cured viral hepatitis are allowed to be included. Past...
- Known HIV infection
- Living attenuated vaccine received within the 30 previous days
- Previous treatment with anti-PD-1, anti-PD-L1, Anti-CTLA4 or any ICI antibody
- Previous treatment with chemotherapy for lung cancer. However, if a patient has a lung adenocarcinoma, previous cisplatin treatment for another cancer type with squamous histology (Head and Neck, bladder) may be allowed...
- General serious condition such as congestive uncontrolled cardiac failure, uncontrolled cardiac arrythmia, uncontrolled ischemic cardiac disease (unstable angina or history of myocardial infarction within the previous 6...
- Pre-existing moderate or severe lung interstitial disease as assessed by the diagnosis CT-scan.
- Inability to comply with study and/or follow-up procedures for family, social, geographic or psychological reasons.
- Pregnant, lactating, or breastfeeding women.
- Patients deprived of liberty by judicial or administrative decision
- Patient who is subject to legal protection or who is unable to express his will
The study team makes the final eligibility decision.
Where it's taking place
- Aix-en-Provence, France
- Amiens, France
- Angers, France
- Avignon, France
- Besançon, France
- Bordeaux, France
- Caen, France
- Cannes, France
- Chauny, France
- Colmar, France
- Dijon, France
- Grenoble, France
- La Roche-sur-Yon, France
- Le Chesnay, France
- Le Mans, France
- Lille, France
- Limoges, France
- Lyon, France
- Marseille, France
- Meaux, France
+ 20 more site(s).
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, 18 years to 74 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aix-en-Provence, France; Amiens, France; Angers, France; Avignon, France; Besançon, France; Bordeaux, France and 34 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.