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New treatment option for Small Cell Lung Cancer Extensive Stage
Official title First Line Pembrolizumab, Plinabulin Plus Etoposide and Platinum (EP) for ES-SCLC
ClinicalTrials.gov ID: NCT05745350
What this study is testing
What is Pembrolizumab, Plinabulin plus Etoposide and Platinum?
Pembrolizumab, Plinabulin plus Etoposide and Platinum is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for small cell lung cancer extensive stage.
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
- Monoclonal antibodies against programmed death 1 (PD-1) and its ligand PD-L1 have shown efficacy in patients with ES-SCLC in the monotherapy and combination therapy settings. Up to now, Atezolizumab and Durvalumab has been approved for first line treatment for ES-SCLC in China combined with EP or EC.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Have a documented new diagnosis of SCLC by histology or cytology from brushing, washing, or needle aspiration of a defined lesion.
- Have extensive stage disease defined as Stage IV (T any, N any, M 1a/b) by the American Joint Committee on Cancer, Eighth Edition.
- Have at least 1 lesion that meets the criteria for being measurable, as defined by RECIST 1.1, and is appropriate for selection as a target lesion...
- Life expectancy ≥3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
You likely can't join if
- Has received prior systemic therapy for the treatment of SCLC.
- Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related...
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used...
- Is expected to require any other form of antineoplastic therapy for SCLC, including radiation therapy, while on study. Note: Patients with PR or CR...
- Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they...
- Has had major surgery within 3 weeks prior to receiving the first dose of trial treatment or has not recovered adequately from toxicity and/or...
See the full eligibility criteria
Who can join
- Have a documented new diagnosis of SCLC by histology or cytology from brushing, washing, or needle aspiration of a defined lesion.
- Have extensive stage disease defined as Stage IV (T any, N any, M 1a/b) by the American Joint Committee on Cancer, Eighth Edition.
- Have at least 1 lesion that meets the criteria for being measurable, as defined by RECIST 1.1, and is appropriate for selection as a target lesion, as determined by local site investigator/radiology review.
- Life expectancy ≥3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Male/female participants who are at least 18 years of age on the day of signing informed consent.
- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
- Have adequate organ function.
- Criteria for known Hepatitis B and C positive people 9.1 Hepatitis B positive people
- Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to treatment.
- Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention. 9.2 Participants with history of HCV infection...
- Male participants: A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 180 days after the last dose of study treatment and refrain...
- A female participant is eligible to participate if she is not pregnant, not breastfeeding.
What rules you out
- Has received prior systemic therapy for the treatment of SCLC.
- Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis...
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of...
- Is expected to require any other form of antineoplastic therapy for SCLC, including radiation therapy, while on study. Note: Patients with PR or CR will be offered PCI therapy at the investigator's consideration at the...
- 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 had major surgery within 3 weeks prior to receiving the first dose of trial treatment or has not recovered adequately from toxicity and/or complications from an intervention prior to receiving the first dose of...
- Has active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine...
- Has symptomatic ascites, pleural effusion, or pericardial effusion. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco or paracentesis) is eligible.
- 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 severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients. Has severe hypersensitivity (≥Grade 3) to plinabulin and/or any of its excipients.
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has a known history of Human Immunodeficiency Virus (HIV) infection.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (ie, CTLA-4, OX-40, CD137) or has previously participated in a MSD...
- Has had an allogenic tissue/solid organ transplant.
- Has received a live vaccine within 30 days prior to the first dose of trial drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow...
- Has a known history of active TB (Bacillus Tuberculosis).
- Any medical conditions that in the Investigator's opinion, would impose excessive risk to the patient. Examples of such conditions include uncontrolled diabetes, infection requiring parenteral anti-infective treatment...
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of trial treatment.
- Active uncontrolled bacterial, viral, or fungal infection requiring systemic therapy.
- 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 first...
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. 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.