BridgeMD
New treatment option for NSCLC (non-small Cell Lung Cancer)
Official title First Line Therapy for Extensive SCLC Patients, Treated with Chemo+Keytruda Followed by Keytuda+Trodelvy
ClinicalTrials.gov ID: NCT06667167
What this study is testing
What is Induction Carboplatin?
Induction Carboplatin is an investigational medicine, being studied as a potential treatment for nsclc (non-small cell lung cancer).
Also referred to as Carboplatin, Etoposide.
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
- Induction phase of carboplatin+etoposide+pembrolizumab followed by maintenance of Pembrolizumab+sacituzumab govitecan
- Phase 2: a mid-size study of how well it works
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 99
You may be able to join if
- Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically or cytologically confirmed...
- The participant has not been previously treated with systemic therapy for ES SCLC (i.e., the disease is treatment naïve). Note: Participants...
- Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs...
- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
- Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Lesions situated in a previously irradiated area are...
You likely can't join if
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory...
- Has received prior systemic anti-cancer therapy including biologic agents or investigational agents or an investigational device within 4 weeks prior...
- Has received prior radiotherapy, chemotherapy, or targeted small molecule therapy within 2 weeks of start of study intervention and have not...
- Have not recovered (i.e., ≥Grade 2 is considered not recovered) from AEs due to a previously administered agent. Note: participants with any grade...
- Have previously received topoisomerase 1 inhibitors.
- Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines...
See the full eligibility criteria
Who can join
- Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically or cytologically confirmed diagnosis of ES SCLC will be enrolled in this study.
- The participant has not been previously treated with systemic therapy for ES SCLC (i.e., the disease is treatment naïve). Note: Participants previously treated for limited SCLC will be allowed with disease-free survival...
- Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who...
- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
- Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- Archival tumor tissue sample or newly obtained [core, incisional or excisional] biopsy of a tumor lesion not previously irradiated has been provided. Note: Participants with asymptomatic brain metastases will be...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Evaluation of ECOG is to be performed within 3 days prior to the first dose of study intervention.
- Life expectancy \>3 months.
- Has adequate organ function as defined in the following table (Table 2). Specimens must be collected within 10 days prior to the start of study intervention.
- A female participant is eligible to participate if she is not pregnant (refer to the Clinical Trials Facilitation and Coordination Group [CTFG] "Recommendations related to contraception and pregnancy testing in clinical...
- Not a woman of childbearing potential (WOCBP) as defined by CTFG Recommendations (Appendix 5) or
- A WOCBP who agrees to follow the contraceptive guidance per CTFG Recommendations (Appendix 5) during the treatment period and for at least 120 days (corresponding to time needed to eliminate any study treatments) after...
What rules you out
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).
- Has received prior systemic anti-cancer therapy including biologic agents or investigational agents or an investigational device within 4 weeks prior to treatment initiation.
- Has received prior radiotherapy, chemotherapy, or targeted small molecule therapy within 2 weeks of start of study intervention and have not recovered from AEs at the time of study entry (i.e., ≥Grade 2 is considered...
- Have not recovered (i.e., ≥Grade 2 is considered not recovered) from AEs due to a previously administered agent. Note: participants with any grade neuropathy or alopecia are an exception to this criterion and will...
- Have previously received topoisomerase 1 inhibitors.
- Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. (Refer to Section 5.5 for information on COVID-19...
- Use of other investigational drugs (drugs not marketed for any indication) within 28 days or 5 half-lives (whichever is longer) of first dose of study drug.
- Has a known hypersensitivity to any of the study treatments, their metabolites, or formulation excipients.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the...
- Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in...
- Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at...
- Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid).
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has an active infection requiring systemic therapy.
- Has an active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months of enrollment.
- Have a history of, or active hepatitis B virus (HBV) or hepatitis C virus (HCV). Note: Testing for Hepatitis B or C is not required unless mandated by local health authority.
- Has not adequately recovered from major surgery or has ongoing surgical complications.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full...
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
- Has had an allogenic tissue/solid organ transplant.
- History of HIV infection. Note: HIV testing is not required unless mandated by local health authority. \-
The study team makes the final eligibility decision.
Where it's taking place
- Jerusalem, Israel, Israel
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 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jerusalem, Israel, Israel. 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.