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Compares treatment options for Carcinoma, Non-Small-Cell Lung
Official title Preoperative Radioimmunotherapy Versus Chemoimmunotherapy in NSCLC
ClinicalTrials.gov ID: NCT06623656
What this study is testing
What is Cemiplimab?
Cemiplimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for carcinoma, non-small-cell lung.
Also referred to as Libtayo, REGN2810.
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
- The goal of this clinical trial is to learn if Cemiplimab with chemotherapy or Cemiplimab with stereotactic body radiation therapy (SBRT) works as treatment for stages IB, II, and III (N2) Non-Small Cell Lung Cancer (NSCLC). Before surgery to remove their lung cancer, participants will take: 1.
- 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 and older
You may be able to join if
- Patients with histologically or cytologically proven clinical stages IB (T2aN0), II, and III(N2) NSCLC (according to AJCC version 9) eligible for...
- Measurable disease, as defined by RECIST v1.1.
- Known PD-L1 expression.
- No known EGFR mutations or ALK fusions.
- Written informed consent and HIPAA obtained from the subject prior to performing any protocol-related procedures.
You likely can't join if
- History of another primary malignancy except for: -Malignancy treated with curative intent and with no known active disease ≥2 years before the first...
- Adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer in situ, in-situ urinary bladder cancer, treated localized...
- Indolent hematological malignancies
- Current or prior use of immunosuppressive medication within 14 days before the first dose of cemiplimab, with the exceptions of intranasal, inhaled...
- Patients with vitiligo or alopecia
- Patients with endocrinopathies (such as hypothyroidism or type 1 diabetes (e.g., following Hashimoto syndrome) stable on hormone replacement, or...
See the full eligibility criteria
Who can join
- Patients with histologically or cytologically proven clinical stages IB (T2aN0), II, and III(N2) NSCLC (according to AJCC version 9) eligible for surgical resection with curative intent. Patients with 2 synchronous...
- Measurable disease, as defined by RECIST v1.1.
- Known PD-L1 expression.
- No known EGFR mutations or ALK fusions.
- Written informed consent and HIPAA obtained from the subject prior to performing any protocol-related procedures.
- Age \> 18 years at time of study entry.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- No prior therapy for lung cancer
- Adequate organ and bone marrow function as defined below:
- Absolute neutrophil count (ANC) ≥1.5 x10(3)/uL
- Platelets ≥75 x10(3)/uL
- Hemoglobin ≥9 g/dL
- Serum creatinine ≤1.5 X upper limit of normal (ULN) OR calculated CrCl ≥50 ml/min (using the Cockcroft-Gault formula).
- Serum total bilirubin ≤1.5 X ULN, except in patients with clinically documented Gilbert's Syndrome where ≤3x the ULN is permitted
- Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) ≤3 X ULN
- WOCBP\ must have a negative serum (beta-hCG) at screening. a) \ WOCBP are defined as women who are fertile following menarche until becoming postmenopausal, unless permanently sterile. Permanent sterilization methods...
- WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the entire trial and until 6 months after last treatment.
- All men must agree not to donate sperm during the trial and for 6 months after receiving the last therapy dose.
What rules you out
- 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 the study drug and of low potential risk for recurrence...
- Adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer in situ, in-situ urinary bladder cancer, treated localized prostate cancer, and ductal carcinoma in-situ.
- Indolent hematological malignancies
- Current or prior use of immunosuppressive medication within 14 days before the first dose of cemiplimab, with the exceptions of intranasal, inhaled, topical steroids, or local steroid injections (e.g.intra articular...
- Patients with vitiligo or alopecia
- Patients with endocrinopathies (such as hypothyroidism or type 1 diabetes (e.g., following Hashimoto syndrome) stable on hormone replacement, or psoriasis that does not require systemic treatment.
- Any chronic skin condition that does not require systemic therapy
- Patients with childhood asthma that has resolved 4. Uncontrolled, intercurrent illness including, but not limited to: ongoing or active infection requiring antibiotics (exception is a brief (≤10 days) course of...
- Participants with known controlled HIV infection (undetectable viral load or HIV RNA PCR) and CD4 count above 250 either spontaneously or on a stable antiviral regimen are eligible. For these participants monitoring...
- Participants with HBsAg positive who have controlled infection (serum HBV DNA PCR that is below the limit of detection and receiving antiviral therapy for hepatitis B) are eligible. Participants with controlled...
- Participants with HBsAg negative but total HBcAb positive are permitted with the following requirements: if HBV DNA PCR is above limit of detection at screening, initiate HBV antiviral therapy before study entry. If...
- Participants who are HCV Ab+ who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to successful prior course of anti-HCV therapy) are eligible. 9\. Female patients who are...
- stable use of combined (estrogen and progestogen-containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition...
- IUD; IUS
- bilateral tubal ligation (occlusion)
- vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the WOCBP study patient and that the vasectomized partner has obtained medical assessment of surgical success for the...
- sexual abstinence
- Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual...
- Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and LAM are not acceptable methods of contraception. Female condom and male condom should not be...
- Sexually active men and their partners must use highly effective contraception as described above. Contraception is not required for men with documented vasectomy. Pregnancy testing and contraception are not required...
- Male participants: a male participants will be excluded from the study if that participant does not agree to use condoms or practice sexual abstinence, unless vasectomized, prior to the initial dose/start of study...
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
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 New York, New York, United States. 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.