Carcinoma, Non-Small-Cell Lung study: Cemiplimab vs Platinum based chemotherapy
Official title Preoperative Radioimmunotherapy Versus Chemoimmunotherapy in NSCLC
ClinicalTrials.gov ID: NCT06623656
What this study is testing
What is Cemiplimab?
An investigational intravenous medicine being studied as a potential treatment for stages IB, II, and III (N2) Non‑Small Cell Lung Cancer (NSCLC). It is designed to block PD‑1 receptors on immune cells to enhance the immune response against cancer cells.
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 study wants to see if adding Cemiplimab to chemotherapy or to stereotactic body radiation therapy (SBRT) improves treatment for stages IB, II, and III (N2) non‑small‑cell lung cancer before surgery.
- Who it's for
- Adults with stage IB, II, or III (N2) non‑small‑cell lung cancer who are scheduled for surgery.
- What's involved
- Participants receive either Cemiplimab plus chemotherapy every 3 weeks for up to 3 doses, or Cemiplimab plus SBRT (radiation) on day 1 followed by SBRT alone on days 2 and 3. After surgery, all receive Cemiplimab for one year.
- Time commitment
- The treatment period lasts about 1 year after surgery, with visits every 3 weeks during the initial phase and regular follow‑up visits during the year of Cemiplimab.
- 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
- 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...
- Any chronic skin condition that does not require systemic therapy
See the full eligibility criteria
- 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.
- 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
- 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.
- 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.
- 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
- 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.
- 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 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.
- 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.
- Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and LAM are not acceptable methods of contraception.
- Sexually active men and their partners must use highly effective contraception as described above. Contraception is not required for men with documented vasectomy.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at New York, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.