AzTrials
AzTrials

Non-Small Cell Lung CancerPhase 2NCT07720167

Cemiplimab for Clinical Stage I, 2-3.9cm, Non-Small Cell Lung Cancer

A Phase 2 study testing Cemiplimab, Carboplatin + Pemetrexed/Paclitaxel and Cisplatin in people with Non-Small Cell Lung Cancer, run by Medical University of South Carolina at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The study will investigate the role of cemiplimab in combination with platinum doublet chemotherapy in stage I resectable non-small cell lung cancer (NSCLC). Sub-4cm NSCLC tumors are highly lethal malignancies, yet no therapies are used in these patients to improve chances of survival with surgery alone. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Cemiplimab, Carboplatin + Pemetrexed/Paclitaxel and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteUnited States
Study dates
1 Nov 2026to 1 Nov 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must have histologically proven NSCLC, clinically staged cT1c or T2a, clinically node-negative (no bronchoscopy is required for screening) using AJCC 9th Edition.
  • Participants must have an SUVmax >6.2 on standard of care staging PET scan, and/or biopsy histology must be consistent with moderate/poorly/or undifferentiated NSCLC.
  • Participants must have pulmonary function study capable of tolerating the proposed lung resection according to the surgeon. This will require post-operative predicted forced expiratory volume (FEV) 1 and diffusing capacity of the lungs for carbon monoxide (DLCO) greater than 40%.
  • Participants must be deemed a surgical candidate with adequate organ function, documented in the electronic medical record (EMR).
  • Participants must have ECOG Performance status 0-1.
  • Participants must have a signed and dated IRB approved written consent form before the performance of any protocol related procedures that are not part of the normal participant care.
  • Participants must be aged >18 years old.

Who cannot join

  • Participants must have no known ALK driver mutations
  • Participants must have no known EGFR mutations.
  • Participants must not have known or suspected active autoimmune disease requiring systemic immunosuppressive treatment within the past two years. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  • Participants must not have any condition treated with chemotherapy or other cancer therapy, including anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody (or any other antibody targeting T-cell co-regulatory pathways).
  • Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
  • Participants must not have history of symptomatic interstitial lung disease.
Show all 25Show fewer
  • Prisoners or subjects who are involuntarily incarcerated or compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness will be excluded from the study.
  • Participants must not have previous history of bone marrow transplant.
  • Participants must not have a known allergy, or history of allergy or hypersensitivity to study drug or any of the excipients.
  • Presence of cardiovascular disease, as defined by:
  • New York Heart Association heart failure classifications of Class II, III, or IV; or myocardial infarction, or acute coronary syndrome within 12 months of first dose of study medication; or b) Transient ischemic attack or stroke within 1 year.
  • Any condition that requires ongoing/continuous corticosteroid or immunosuppressive therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 1 week prior to the first dose of study medication. Participants who require a brief course of steroids (up to 2 days in the week before enrollment) or physiologic replacement are not excluded.
  • Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first dose of study medication.
  • Known infection with HIV, hepatitis B or hepatitis C infection, diagnosis of immunodeficiency, and/or tuberculosis (active or latent).
  • Exclusions relating to vaccines:
  • Receipt of a live vaccine within 4 weeks of start of study medication. b) Receipt of COVID-19 vaccination within 1 week of planned start of study medication or for which the planned COVID-19 vaccinations would not be completed 1 week prior to start of study medication.
  • Exclusions and information relating to pregnancy/contraception:
  • WOCBP* and men** who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose. Highly effective contraceptive measures include:
  • Stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening; ii. Intrauterine device; intrauterine hormone-releasing system; iii. Bilateral tubal occlusion/ligation; iv. Vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the WOCBP study participant and that the vasectomized partner has obtained medical assessment of surgical success for the procedure); and/or v. Sexual abstinence†,‡.
  • Note: Pregnancy testing and contraception are required for WOCBP. Pregnancy testing and contraception are not required for women who are postmenopausal or permanently sterile.
  • WOCBP are defined as women who are fertile following menarche until becoming postmenopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.
  • A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high FSH level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to determine the occurrence of a postmenopausal state. The above definitions are according to the CTFG guidance. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
  • Male participants: A male participant 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 medication, during the study, and for at least 6 months after the last dose. Sperm donation is also prohibited during the same period. Vasectomy success must be confirmed by semen analysis.
  • †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 drugs. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant.
  • Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception. Female condom and male condom should not be used together.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

HCC Clinical Trials Office contact

843-792-9321

hcc-clinical-trials@musc.edu

United States1 site

  • Medical University of South Carolina Hollings Cancer Center

    Charleston, South Carolina, 29425

    HCC Clinical Trials Office, 843-792-9321, hcc-clinical-trials@musc.edu

Other trials in United States

About this study

Official title: Neoadjuvant Chemo-Cemiplimab for Clinical Stage I, 2-3.9cm, Non-Small Cell Lung Cancer

The study will investigate the role of cemiplimab in combination with platinum doublet chemotherapy in stage I resectable non-small cell lung cancer (NSCLC). Sub-4cm NSCLC tumors are highly lethal malignancies, yet no therapies are used in these patients to improve chances of survival with surgery alone. Here will be examined the ability of 3 cycles of cemiplimab-chemotherapy to induce pathologic complete responses to treatment.

Being tested
Cemiplimab, Carboplatin + Pemetrexed/Paclitaxel, Cisplatin
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CemiplimabDrug

    administered at a dose of 350 mg as an intravenous infusion over 30 minutes

  • Carboplatin + Pemetrexed/PaclitaxelDrug

    every 21 days for three cycles if not using cisplatin

  • CisplatinDrug

    every 21 days for three cycles if not using carboplatin and pemetrexed/paclitaxel

Study groups in NCT07720167
Study groupRoleWhat they receive
Cemiplimab+Investigator's choice platinum doublet for clinical stage 1, 2-3.9cm, NSCLCExperimentalPatients will receive carboplatin + pemetrexed/paclitaxel or cisplatin. Followed by surgery. Safety labs and physical exam 3 weeks post-surgery. Long-term follow up.
Receives: Drug: Cemiplimab; Drug: Carboplatin + Pemetrexed/Paclitaxel; Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency and percentage of patients with a pathologic complete response (pCR) rate

    defined as the rate of ypT0N0 stage disease based on AJCC and UICC staging systems

    Measured: 5.5 years

Secondary outcomes (5)

  1. Frequency and grade of adverse events and serious adverse events

    based on CTCAE v5.0

    Measured: 5.5 years

  2. Relapse-free survival

    defined as the time interval from date of surgery until disease recurrence or death due to any cause.

    Measured: 5.5 years

  3. Overall survival

    defined as the time interval from C1D1 of treatment with the investigational intervention to death due to any cause.

    Measured: 5.5 years

  4. frequency and percentage surgical margin status based on residual (R) tumor classification (R0, R1, R2)

    will be summarized by the frequency and percentage of patients classified as R0, R1, and R2 based on residual tumor classification

    Measured: 5.5 years

  5. frequencies and percentages of delayed or cancelled surgeries

    Number and proportion of delayed or cancelled surgeries

    Measured: 5.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion1 Nov 2029 (estimated)
  4. Study completion1 Nov 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07720167
Sponsor's protocol ID
104130
Status last verified
Jul 2026
First submitted
17 Jul 2026
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cemiplimab, Carboplatin + Pemetrexed/Paclitaxel and Cisplatin in people with Non-Small Cell Lung Cancer, run by Medical University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact HCC Clinical Trials Office (843-792-9321, hcc-clinical-trials@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency and percentage of patients with a pathologic complete response (pCR) rate (time frame: 5.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07720167.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in