NSCLC Stage IVPhase 2LUNGVIRNCT05597800

Nivolumab/Ipilimumab and Chemotherapy Combination in Advanced NSCLC Patients With HIV, HBV, HCV and Long Covid Syndrome

A Phase 2 study testing Nivolumab and Ipilimumab in people with NSCLC Stage IV and HIV, run by Universita di Verona at 1 site in Italy.

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

Study type: Phase 2 - Interventional Trial Number of patients to be enrolled: 105 Participating countries: Italy Study drugs: nivolumab and ipilimumab Cohort A: HBV and HCV patients Cohort B: HIV patients Cohort C: Long COVID syndrome The stratification factors are HBV/HCV positive (cohort A), HIV positive (cohort B)… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: NSCLC Stage IV, HIV, HBV
What is being tested?: Nivolumab and Ipilimumab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 105 participants
Where: 1 siteItaly
Study dates: 1 Feb 2023to 30 Mar 2027
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants must have histologically confirmed diagnosis of metastatic or unresectable NSCLC;
No sensitizing EGFR, ALK, ROS1, BRAF and NTRK alterations;
Eastern Cooperative Oncology Group (ECOG) score 0-1 (physically able to carry out light housework or office work through to being fully active as they were before cancer);
No prior systemic anticancer therapy;
Tissue or Programmed death-ligand 1 (PD-L1) results available;
HIV-1 or HIV-2 chronic infection, defined as i) a positive HIV 1-2 western blot or other FDA/CE approved HIV confirmatory test (regardless the results of the HIV 1-2 screening test used [2nd, 3rd, 4th generation tests, rapid tests or laboratory tests (i.e., ELISA, EIA, CLIA, etc.)], ii) the referring physician's written record that HIV infection was documented, with supporting information on the participant's relevant medical history and/or current antiretroviral treatment for HIV infection;

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Only subjects with chronic or resolved HBV infections might be eligible. Chronic HBV infections is defined as: the persistence of HBsAg positivity for more than 6 months (regardless HBeAg result, HBV-DNA level and the presence of liver necroinflammation). Resolved HBV infection is defined by: the absence of liver inflammation (clinically and laboratory), HBsAg negativity and HBsAb (anti-HBs antibodies) and HBcAb (anti-HBc IgG) positive result;
Only subjects with resolved HCV infections might be eligible. Subjects with a newly diagnosed chronic HCV infection (defined as: positive HCV antibodies + detectable HCV-RNA) should be treated for HCV infection before enrollment. Acute HCV infection [defined as a positive HCV-RNA and i) a negative serological HCV assay (HCV-Ab) or ii) a positive serological HCV assay (HCV-Ab) with a negative test 6 months earlier] cannot be enrolled in the study.
Patients with past HCV infection, with no evidence of chronic infection (i.e., anti-HCV antibody positivity, HCV-RNA negativity) should be excluded;
Patients with confirmed Long Covid syndrome or PASC defined, as suggest by World Health Organization (WHO), as "condition occurs in individuals with a history of probable or confirmed SARS CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms and that last for at least 2 months and cannot be explained by an alternative diagnosis". This condition must be present at enrollment;
Participants must have a nasopharyngeal swab positive for Sars-Cov2 within 12 months before enrolment;
Participants must be either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to first treatment;
Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam; scans must have been performed within 4 weeks prior to registration.
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug;
Ability to understand and to sign a written informed consent document.

Who cannot join

Eastern Cooperative Oncology Group (ECOG) score ≥2;
Untreated symptomatic brain metastases or leptomeningeal metastases;
Another active concomitant malignancy;
Active, known or suspected, autoimmune disease;
Active HBV or HCV infection, presence of any infectious disease requiring specific treatment.
Active Sars-Cov2 infection.

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

Centro Ricerche Cliniche
Verona, Veneto/Verona, 37134
Stefano Milleri, MD, +39 045 8126509, stefano.milleri@crc.vr.it
Sara Pilotto, MD, PhD

Other trials in Italy

About this study

Official title: A Phase 2, Multicenter, Open Label, Clinical Trial Evaluating Safety and Activity of Nivolumab/Ipilimumab and Chemotherapy Combination in Advanced NSCLC Patients With HIV, HBV, HCV and Post-acute Sequelae of SARS-CoV2 Infection (PASC).

Read the detailed description

Participants (≥ 18 years) must have histologically confirmed metastatic or unresectable non-small cell lung cancer (both non-squamous and squamous), without sensitizing EGFR, ALK, ROS1, BRAF and NTRK alterations, with chronic viral infections, such as HBV and HCV in cohort A and HIV in cohort B and with Long Covid syndrome in Cohort C.

The study is a multicenter, open-label trial designed according to Bryant and Day and including 1) a screening phase to establish study eligibility, 2) an open-label treatment phase, in which patients will receive nivolumab plus ipilimumab in combination with histology-based chemotherapy (2 induction cycles) to ascertain its safety, defined as incidence of grade 3 or 4 (G3/4) treatment-related adverse events (TRAEs) and activity, 3) and a follow-up phase to monitor survival status and subsequent therapies.

In detail, the study includes:

A screening phase to establish study eligibility (including, for example, the availability of tumour tissue for molecular analyses) and document baseline assessments.
An open-label treatment phase, in which patients will be treated with 2 cycles of chemotherapy and nivolumab plus ipilimumab until disease progression, unacceptable toxicity or for a maximum of 2 years. Upon disease progression or completion of trial treatment, further therapy will be at the discretion of the treating physician.
A follow-up phase, to monitor safety, survival status and subsequent therapies.

Conditions: NSCLC Stage IV, HIV, HBV, HCV, Long COVID
Being tested: Nivolumab and Ipilimumab
Medical subject headings: Carcinoma, Non-Small-Cell Lung, Post-Acute COVID-19 Syndrome

What participants receive

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

Nivolumab and IpilimumabDrug
Also called Opdivo and Yervoy
Nivolumab will be administered with ipilimumab, plus 2 cycles of histology-based platinum doublet chemotherapy:
- Squamous histology: carboplatin AUC 6 + paclitaxel 200 mg/m2
- Non-squamous histology: carboplatin AUC 5 or 6 + pemetrexed 500 mg/m2 or cisplatin 75 mg/m2 + pemetrexed 500 mg/m Dosing: nivolumab 360 mg every 3 weeks + ipilimumab 1 mg/kg every 6 weeks (up to maximum 2 years) + histology-based, platinum doublet chemotherapy (every 3 weeks for two cycles).

Study groups in NCT05597800
Study group	Role	What they receive
Cohort A: HBV and HCV patients	Experimental	Participants (≥ 18 years) must have histologically confirmed metastatic or unresectable non-small cell lung cancer (both non-squamous and squamous), without sensitizing EGFR, ALK, ROS1, BRAF and NTRK alterations, with chronic viral infections, such as HBV and HCV in cohort A. Squamous histology: carboplatin AUC 6 + paclitaxel 200 mg/m2 Non-squamous histology: carboplatin AUC 5 or 6 + pemetrexed 500 mg/m2 or cisplatin 75 mg/m2 + pemetrexed 500 mg/m2. Receives: Drug: Nivolumab and Ipilimumab
Cohort B: HIV patients	Experimental	Participants (≥ 18 years) must have histologically confirmed metastatic or unresectable non-small cell lung cancer (both non-squamous and squamous), without sensitizing EGFR, ALK, ROS1, BRAF and NTRK alterations, with chronic viral infections such as HIV in cohort B. Squamous histology: carboplatin AUC 6 + paclitaxel 200 mg/m2 Non-squamous histology: carboplatin AUC 5 or 6 + pemetrexed 500 mg/m2 or cisplatin 75 mg/m2 + pemetrexed 500 mg/m2. Receives: Drug: Nivolumab and Ipilimumab
Cohort C: Long COVID syndrome	Experimental	Participants (≥ 18 years) must have histologically confirmed metastatic or unresectable non-small cell lung cancer (both non-squamous and squamous), without sensitizing EGFR, ALK, ROS1, BRAF and NTRK alterations, with chronic viral infections such as Long Covid syndrome in Cohort C. Squamous histology: carboplatin AUC 6 + paclitaxel 200 mg/m2 Non-squamous histology: carboplatin AUC 5 or 6 + pemetrexed 500 mg/m2 or cisplatin 75 mg/m2 + pemetrexed 500 mg/m2. Receives: Drug: Nivolumab and Ipilimumab

What is being measured

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

Safety, defined as onset of grade 3 or 4 (G3/4) treatment-related adverse events (TRAEs), assessed by the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 5.
The primary objectives of the study are safety, defined as onset of grade 3 or 4 (G3/4) treatment-related adverse events (TRAEs), assessed by the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 5.
Measured: 3 years
Objective Response Rate (ORR) measured as for RECIST 1.1 criteria
Activity in terms of objective response rate (ORR) of nivolumab plus ipilimumab in combination with platinum-based chemotherapy (2 cycles) in first-line advanced NSCLC patients with chronic viral infections.
Measured: 3 years

Secondary outcomes (3)

Overall survival (OS)
Overall survival (OS) is defined as the time between the date of the randomization date and the date of death due to any cause. OS will be censored on the last date a participant was known to be alive.
Measured: 3 years
Progression-free survival (PFS)
Progression free survival (PFS), according to response evaluation criteria in solid tumors (RECIST) 1.1 as assessed by local investigators, is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD is defined as a ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.
Measured: 3 years
Duration of response (DOR)
Duration of response (DOR) is defined as the time from date of first documentation of confirmed response (CR or PR) to date of first documentation of progression or symptomatic deterioration, or death due to any cause among patients who achieve, assessed at 6 and 12 months.
Measured: 3 years

Timeline

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

1 Feb 202330 Mar 2027

First posted28 Oct 2022
Study start1 Feb 2023 (estimated)
Primary completion31 Dec 2026 (estimated)
Study completion30 Mar 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for NSCLC Stage IVStudies 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: Non-randomised
Intervention model: Parallel groups
Model description: Study type: Phase 2 - Interventional Trial Study drugs: nivolumab and ipilimumab Cohort A: HBV and HCV patients Cohort B: HIV patients Cohort C: Long COVID syndrome
Masking: None (open label)
Enrolment: 105 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05597800
Sponsor's protocol ID: 2022-002313-41
Other IDs: 2022-002313-41
Acronym: LUNGVIR
Status last verified: Oct 2022
First submitted: 21 Oct 2022
Last updated: 28 Oct 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Multicenter, Open Label, Clinical Trial Evaluating Safety and Activity of Nivolumab/Ipilimumab and Chemotherapy Combination in Advanced NSCLC Patients With HIV, HBV, HCV and Post-acute Sequelae of SARS-CoV2 Infection (PASC).
ClinicalTrials.gov ID: NCT05597800
Acronym / sponsor ID: LUNGVIR / 2022-002313-41
Conditions: NSCLC Stage IV, HIV, HBV, HCV, Long COVID
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 105 participants (estimated)
Lead sponsor: Universita di VeronaUniversity, hospital or other
Study start: 1 Feb 2023 (estimated)
Primary completion: 31 Dec 2026 (estimated)
Study completion: 30 Mar 2027 (estimated)
First posted: 28 Oct 2022 (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.

Detailed description

In detail, the study includes:

A screening phase to establish study eligibility (including, for example, the availability of tumour tissue for molecular analyses) and document baseline assessments.
An open-label treatment phase, in which patients will be treated with 2 cycles of chemotherapy and nivolumab plus ipilimumab until disease progression, unacceptable toxicity or for a maximum of 2 years. Upon disease progression or completion of trial treatment, further therapy will be at the discretion of the treating physician.
A follow-up phase, to monitor safety, survival status and subsequent therapies.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Study type: Phase 2 - Interventional Trial Study drugs: nivolumab and ipilimumab Cohort A: HBV and HCV patients Cohort B: HIV patients Cohort C: Long COVID syndrome

Arm	Type	Receives
Cohort A: HBV and HCV patients	Experimental	Drug: Nivolumab and IpilimumabParticipants (≥ 18 years) must have histologically confirmed metastatic or unresectable non-small cell lung cancer (both non-squamous and squamous), without sensitizing EGFR, ALK, ROS1, BRAF and NTRK alterations, with chronic viral infections, such as HBV and HCV in cohort A. Squamous histology: carboplatin AUC 6 + paclitaxel 200 mg/m2 Non-squamous histology: carboplatin AUC 5 or 6 + pemetrexed 500 mg/m2 or cisplatin 75 mg/m2 + pemetrexed 500 mg/m2.
Cohort B: HIV patients	Experimental	Drug: Nivolumab and IpilimumabParticipants (≥ 18 years) must have histologically confirmed metastatic or unresectable non-small cell lung cancer (both non-squamous and squamous), without sensitizing EGFR, ALK, ROS1, BRAF and NTRK alterations, with chronic viral infections such as HIV in cohort B. Squamous histology: carboplatin AUC 6 + paclitaxel 200 mg/m2 Non-squamous histology: carboplatin AUC 5 or 6 + pemetrexed 500 mg/m2 or cisplatin 75 mg/m2 + pemetrexed 500 mg/m2.
Cohort C: Long COVID syndrome	Experimental	Drug: Nivolumab and IpilimumabParticipants (≥ 18 years) must have histologically confirmed metastatic or unresectable non-small cell lung cancer (both non-squamous and squamous), without sensitizing EGFR, ALK, ROS1, BRAF and NTRK alterations, with chronic viral infections such as Long Covid syndrome in Cohort C. Squamous histology: carboplatin AUC 6 + paclitaxel 200 mg/m2 Non-squamous histology: carboplatin AUC 5 or 6 + pemetrexed 500 mg/m2 or cisplatin 75 mg/m2 + pemetrexed 500 mg/m2.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Participants must have histologically confirmed diagnosis of metastatic or unresectable NSCLC;
No sensitizing EGFR, ALK, ROS1, BRAF and NTRK alterations;
Eastern Cooperative Oncology Group (ECOG) score 0-1 (physically able to carry out light housework or office work through to being fully active as they were before cancer);
No prior systemic anticancer therapy;
Tissue or Programmed death-ligand 1 (PD-L1) results available;

Key exclusion criteria (6 listed)

Eastern Cooperative Oncology Group (ECOG) score ≥2;
Untreated symptomatic brain metastases or leptomeningeal metastases;
Another active concomitant malignancy;
Active, known or suspected, autoimmune disease;
Active HBV or HCV infection, presence of any infectious disease requiring specific treatment.

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
Nivolumab and IpilimumabAlso: Opdivo and YervoyNivolumab will be administered with ipilimumab, plus 2 cycles of histology-based platinum doublet chemotherapy: * Squamous histology: carboplatin AUC 6 + paclitaxel 200 mg/m2 * Non-squamous histology: carboplatin AUC 5 or 6 + pemetrexed 500 mg/m2 or cisplatin 75 mg/m2 + pemetrexed 500 mg/m Dosing: nivolumab 360 mg every 3 weeks + ipilimumab 1 mg/kg every 6 weeks (up to maximum 2 years) + histology-based, platinum doublet chemotherapy (every 3 weeks for two cycles).	Drug	Cohort A: HBV and HCV patients, Cohort B: HIV patients, Cohort C: Long COVID syndrome

Primary outcome

Safety, defined as onset of grade 3 or 4 (G3/4) treatment-related adverse events (TRAEs), assessed by the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 5.
Time frame: 3 years
The primary objectives of the study are safety, defined as onset of grade 3 or 4 (G3/4) treatment-related adverse events (TRAEs), assessed by the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 5.
Objective Response Rate (ORR) measured as for RECIST 1.1 criteria
Time frame: 3 years
Activity in terms of objective response rate (ORR) of nivolumab plus ipilimumab in combination with platinum-based chemotherapy (2 cycles) in first-line advanced NSCLC patients with chronic viral infections.

3 secondary outcomes

Overall survival (OS)
Time frame: 3 years
Progression-free survival (PFS)
Time frame: 3 years
Duration of response (DOR)
Time frame: 3 years

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 28 Oct 2022.
Individual participant dataSharing planned: No

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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.

Centro Ricerche Cliniche

Verona, Italy

+39 045 8126509

stefano.milleri@crc.vr.it

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 Nivolumab and Ipilimumab in people with NSCLC Stage IV and HIV, run by Universita di Verona 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 15 inclusion and 6 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 28 Oct 2022. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety, defined as onset of grade 3 or 4 (G3/4) treatment-related adverse events (TRAEs), assessed by the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 5. (time frame: 3 years). The study lists 2 primary outcomes in all. 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 NCT05597800.

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 28 Oct 2022.