NSCLCPhase 2CemitedNCT07264673
A Randomized Phase II Trial of Cemiplimab Plus OSE2101 ( TEDOPI®) as Maintenance Therapy in ctDNA Positive NSCL. The Cemited Study.
A Phase 2 study testing Tedopi and Cemiplimab in people with NSCLC, run by Fondazione Ricerca Traslazionale at 1 site in Italy.
Trial summary
This is a phase II randomized study investigating whether a combination maintenance with Cemiplimab and OSE2101 (TEDOPI®) could increase ctDNA clearance rate versus standard maintenance therapy in HLA-A2 positive NSCLC patients not progressing after 4 cycles of chemo-immunotherapy. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- NSCLC
- What is being tested?
- Tedopi and Cemiplimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteItaly
- Study dates
- 17 Apr 2025to Oct 2029
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed diagnosis of non- oncogene addicted advanced, locally advanced (not suitable for definitive chemoradiation therapy) or metastatic non-small-cell lung cancer (NSCLC)
- Any patient candidate for first line chemo-immunotherapy irrespective of PD-L1 levels
- HLA-A2 positive
- ECOG PS 0-1
- Signed informed consent (IC) prior to any trial-specific procedures
Who cannot join
- Patients not candidate for chemo-immunotherapy
- HLA-A2 negative
- Symptomatic or not previously treated and not stable brain metastases. Brain metastases are allowed if asymptomatic or pretreated
- Tumor tissue not available (archive or collected before trial inclusion)
- Evidence of EGFR mutations or ALK or ROS1 rearrangements
- Performance status >1 (ECOG)
- Diagnosis of another cancer in the last 3 years, except for in situ carcinoma of cervix, breast and bladder or skin carcinoma(squamous or basaloid)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituti Fisioterapici Ospitalieri- Ifo - Istituto Regina Elena
Roma, RM, 00144
Federico Cappuzzo, MD, 06.5266.5698 ext. +39, federico.cappuzzo@ifo.it
Lorenza Landi, MD, 3397728272 ext. +39, lorenza.landi@ifo.it
About this study
This is a phase II randomized study investigating whether a combination maintenance with Cemiplimab and OSE2101 (TEDOPI®) could increase ctDNA clearance rate versus standard maintenance therapy in HLA-A2 positive NSCLC patients not progressing after 4 cycles of chemo-immunotherapy.
Read the detailed description
This is a phase II randomized study investigating whether a combination maintenance with Cemiplimab and OSE2101 (TEDOPI®) could increase ctDNA clearance rate versus standard maintenance therapy in HLA-A2 positive NSCLC patients not progressing after 4 cycles of chemo-immunotherapy.
NSCLC patients with any histology, irrespective of PD-L1 expression levels and candidates for first line metastatic therapy will be screened for HLA-A2 status.
After evaluation of all inclusion and exclusion criteria and after informed consent signature, all eligible patients will receive up to four cycles of chemotherapy and Cemiplimab. The chemotherapy regimen will be selected by the investigator, in accordance with current clinical practice, favoring the use of platinum-based chemotherapy agents.
Patients not progressing after 4 cycles of chemo-immunotherapy will be evaluated for the cTDNA presence (baseline).
If they are positive for ctDNA will be further randomized to standard maintenance therapy or to the combination maintenance of Cemiplimab and OSE2101 (TEDOPI®). In case of ctDNA negative test will be treated with Cemiplimab according to clinical practice.
ctDNA will be further evaluated before cycle 3, and at the time of disease progression or at the end of maintenance therapy.
To summarize ctDNA will be analyzed in patients not progressing after 4 cycles of chemo-immunotherapy (before randomization), during the maintenance therapy and at the time of progression.
An additional blood sample will be collected in all patients at the time of starting first-line chemo-immunotherapy (pre-baseline).
- Conditions
- NSCLC
- Being tested
- Tedopi, Cemiplimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TedopiDrug
Also called Cemiplimab
Cemiplimab + OSE2101 (TEDOPI®) (ARM B: experimental arm)
CemiplimabDrug
Cemiplimab +/-Pemetrexed (ARM A: standard arm)
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Cemiplimab 350 mg iv q21 single agent (squamous histology) or Cemiplimab 350 mg iv q21 plus pemetrexed 500mg/m2 q21 (non- squamous histology). Receives: Drug: Cemiplimab |
| B | Experimental | Cemiplimab 350 mg iv q 21 plus OSE2101 (TEDOPI®). The OSE2101 (TEDOPI®) dose to be injected is of 1 mL (5 mg of drug product) by subcutaneousubcutaneous administration Receives: Drug: Tedopi |
What is being measured
The primary outcome is the main question the study is designed to answer.
ctDNA clearance rate
Differences in ctDNA clearance rate in the two arms of treatment
Differences in ctDNA clearance rate in the two arms of treatment
Differences in ctDNA clearance rate in the two arms of treatment
Differences in ctDNA clearance rate in the two arms of treatment
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start17 Apr 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- phase II randomized study
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Ricerca Traslazionale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264673
- Sponsor's protocol ID
- CEMITED
- Acronym
- Cemited
- Status last verified
- Nov 2025
- First submitted
- 24 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial of Cemiplimab Plus OSE2101 ( TEDOPI®) as Maintenance Therapy in ctDNA Positive NSCL. The Cemited Study.
- ClinicalTrials.gov ID
- NCT07264673
- Acronym / sponsor ID
- Cemited / CEMITED
- Conditions
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Fondazione Ricerca TraslazionaleUniversity, hospital or other
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II randomized study investigating whether a combination maintenance with Cemiplimab and OSE2101 (TEDOPI®) could increase ctDNA clearance rate versus standard maintenance therapy in HLA-A2 positive NSCLC patients not progressing after 4 cycles of chemo-immunotherapy.
Detailed description
This is a phase II randomized study investigating whether a combination maintenance with Cemiplimab and OSE2101 (TEDOPI®) could increase ctDNA clearance rate versus standard maintenance therapy in HLA-A2 positive NSCLC patients not progressing after 4 cycles of chemo-immunotherapy.
NSCLC patients with any histology, irrespective of PD-L1 expression levels and candidates for first line metastatic therapy will be screened for HLA-A2 status.
After evaluation of all inclusion and exclusion criteria and after informed consent signature, all eligible patients will receive up to four cycles of chemotherapy and Cemiplimab. The chemotherapy regimen will be selected by the investigator, in accordance with current clinical practice, favoring the use of platinum-based chemotherapy agents.
Patients not progressing after 4 cycles of chemo-immunotherapy will be evaluated for the cTDNA presence (baseline).
If they are positive for ctDNA will be further randomized to standard maintenance therapy or to the combination maintenance of Cemiplimab and OSE2101 (TEDOPI®). In case of ctDNA negative test will be treated with Cemiplimab according to clinical practice.
ctDNA will be further evaluated before cycle 3, and at the time of disease progression or at the end of maintenance therapy.
To summarize ctDNA will be analyzed in patients not progressing after 4 cycles of chemo-immunotherapy (before randomization), during the maintenance therapy and at the time of progression.
An additional blood sample will be collected in all patients at the time of starting first-line chemo-immunotherapy (pre-baseline).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- phase II randomized study
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: CemiplimabCemiplimab 350 mg iv q21 single agent (squamous histology) or Cemiplimab 350 mg iv q21 plus pemetrexed 500mg/m2 q21 (non- squamous histology). |
| B | Experimental | Drug: TedopiCemiplimab 350 mg iv q 21 plus OSE2101 (TEDOPI®). The OSE2101 (TEDOPI®) dose to be injected is of 1 mL (5 mg of drug product) by subcutaneousubcutaneous administration |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed diagnosis of non- oncogene addicted advanced, locally advanced (not suitable for definitive chemoradiation therapy) or metastatic non-small-cell lung cancer (NSCLC)
- Any patient candidate for first line chemo-immunotherapy irrespective of PD-L1 levels
- HLA-A2 positive
- ECOG PS 0-1
- Signed informed consent (IC) prior to any trial-specific procedures
Key exclusion criteria (7 listed)
- Patients not candidate for chemo-immunotherapy
- HLA-A2 negative
- Symptomatic or not previously treated and not stable brain metastases. Brain metastases are allowed if asymptomatic or pretreated
- Tumor tissue not available (archive or collected before trial inclusion)
- Evidence of EGFR mutations or ALK or ROS1 rearrangements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TedopiAlso: CemiplimabCemiplimab + OSE2101 (TEDOPI®) (ARM B: experimental arm) | Drug | B |
| CemiplimabCemiplimab +/-Pemetrexed (ARM A: standard arm) | Drug | A |
Primary outcome
ctDNA clearance rate
Time frame: 48 months
Differences in ctDNA clearance rate in the two arms of treatment Differences in ctDNA clearance rate in the two arms of treatment Differences in ctDNA clearance rate in the two arms of treatment Differences in ctDNA clearance rate in the two arms of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tedopi and Cemiplimab in people with NSCLC, run by Fondazione Ricerca Traslazionale at 1 site in Italy.
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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 4 Dec 2025. 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 Italy. 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 Federico Cappuzzo, Medical Oncology (+390652665789, federico.cappuzzo@fondazionefort.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ctDNA clearance rate (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2025.