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Lung Squamous Cell CarcinomaPhase 2NCT07038915

STRIVE: A Single-arm Phase 2 Study on Treatment of Lung Squamous Cell Carcinoma by Tiragolumab Plus Ivonescimab for Patients Who Progressed on Platinum Doublets and Anti-PD-1/PD-L1

A Phase 2 study testing Tiragolumab and Ivonescimab in people with Lung Squamous Cell Carcinoma and Anti-PD1/PDL1 Antibody, run by M.D. Anderson Cancer Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

To learn if the drug combination of tiragolumab and ivonescimab can help to control LSCC that got worse after standard treatment with platinum doublets and anti-PD-1/PD-L1 therapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tiragolumab and Ivonescimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
28 Jul 2025to 28 Jul 2025
Phase
Phase 2
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Prior treatment with anti-TIGIT antibody therapy
  • Symptomatic central nervous system (CNS) metastases
  • History of leptomeningeal disease
  • Uncontrolled tumor-related pain Participants requiring pain medication must be on a stable regimen at study entry.
  • Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrollment. Participants should be recovered from the effects of radiation. There is no required minimum recovery period.
  • Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to enrollment.
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  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) Participants with indwelling catheters (e.g., PleurX) are allowed.
  • Uncontrolled or symptomatic hypercalcemia (ionized calcium >1.5 mmol/L, calcium >12 mg/dL or corrected serum calcium > ULN
  • Active or history of clinically significant autoimmune disease that, in the opinion of the investigator, could compromise the health and safety of the patient if treated with investigational therapy. Notable exceptions include:
  • Participants with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone
  • Participants with controlled type 1 diabetes mellitus who are on an insulin regimen
  • Active or history of adrenal insufficiency on stable steroid regimen
  • Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only are eligible for the study provided all of following conditions are met:
  • Disease is well controlled at baseline and requires only low-potency topical corticosteroids ii. No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency oral corticosteroids within the previous 12 months
  • History of bleeding tendencies or coagulopathy and/or clinically significant bleeding symptoms or risk within 4 weeks prior to enrollment, including but not limited to:
  • Gastrointestinal bleeding
  • Hemoptysis (defined as coughing up ≥ 1 teaspoon of fresh blood or blood clots) Note: transient hemoptysis associated with diagnostic bronchoscopy is allowed.
  • Nasal bleeding /epistaxis (bloody nasal discharge is allowed)
  • Need for therapeutic anticoagulant therapy within 14 days prior to enrollment Note: Prophylactic anticoagulation for DVT/PE or to maintain venous patency is allowed.
  • Other intermediate to high bleeding risks determined by treating physicians
  • Imaging during the screening period shows that the patient has:
  • Radiologically documented evidence of major blood vessel invasion or encasement by cancer
  • Radiographic evidence of intratumor cavitation
  • Active idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
  • Known active tuberculosis
  • Major surgical procedures or serious trauma within 4 weeks prior to enrollment, or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to enrollment
  • Active malignancy other than NSCLC that requires treatment, with the exception of malignancies with a negligible risk of metastasis or death as assessed and confirmed by the study principal investigator (PI). Possible examples include: adequately treated carcinoma in situ of the cervix, non melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer
  • Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment Participants receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.
  • Severe infection within 2 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection (including coronavirus disease 2019 [COVID-19]), bacteremia, or severe pneumonia
  • Prior allogeneic stem cell or solid organ transplantation
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the view of the investigator, contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
  • Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during study treatment or within 5 months after the final dose of study treatment of tiragolumab or ivonescimab
  • Positive Epstein-Barr virus (EBV) viral capsid antigen immunoglobulin M (IgM) test at screening An EBV polymerase chain reaction (PCR) test should be performed as clinically indicated to screen for acute infection or suspected chronic active infection. Participants with a positive EBV PCR test are excluded.
  • Treatment with investigational therapy within 21 days prior to initiation of study treatment
  • Prior immune-related adverse event resulting in permanent discontinuation of immune checkpoint blockade therapy including but not limited to anti-PD-1, anti-PD-L1 and anti-CTLA4 therapeutic antibodies that, in the view of the investigator, could compromise health and safety of prospective patient if enrolled in the study
  • Inadequately controlled hypertension (defined as systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg). Anti-hypertensive therapy to achieve these parameters is allowable
  • Prior history of hypertensive crisis or hypertensive encephalopathy
  • History of major diseases before enrollment, specifically:
  • Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association [NYHA] classification ≥ grade 2) or vascular disease (eg, aortic aneurysm at risk of rupture) that required hospitalization within 12 months prior to enrollment, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia)
  • History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months before enrollment
  • History of arterial thromboembolic event, venous thromboembolic event of Grade 3 and above as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months prior to enrollment
  • Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before enrollment
  • History of perforation of the gastrointestinal tract and/or fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to enrollment
  • History of intracranial bleeding within 1 year if initiation of treatment
  • Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, < 7 days prior to the first dose of study treatment
  • Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture
  • Proteinuria, as demonstrated by urine dipstick or > 1.0 g of protein in a 24-hour urine collection. All Participants with >= 2+ protein on dipstick urinalysis at baseline must undergo a 24-hour urine collection for protein
  • Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and IL-2) within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
  • Treatment with systemic immunosuppressive medication (including, but not limited to: corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-alpha agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions: a. Participants who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after PI confirmation has been obtained b. Participants who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study
  • History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins • Known hypersensitivity to Chinese hamster ovary cell products or to any component of the tiragolumab and ivonescimab formulation. Tiragolumab (formerly MTIG7192A) is a fully human IgG1 monoclonal antibiody derived in open monoclonal technology rats that binds to TIGIT and prevents its interaction with the poliovirus receptor. The recombinant antibody is produced in Chinese hamster ovary (CHO) cells and consists of two heavy chains (456 amino acid residues each) and two light chains (220 amino acid residues each).
  • Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 6 months after the final dose of study treatment. Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment.

About this study

To learn if the drug combination of tiragolumab and ivonescimab can help to control LSCC that got worse after standard treatment with platinum doublets and anti-PD-1/PD-L1 therapy.

Read the detailed description

Primary Objectives To determine the objective response rate (ORR) of metastatic LSCC patients who progressed on platinum doublets and anti-PD1/PD-L1 treated with Tiragolumab/Ivonescimab.

Secondary Objectives To evaluate the investigator assessed progression-free survival (PFS) and overall survival (OS) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 of tiragolumab in combination with ivonescimab To evaluate the duration of response (DoR) of tiragolumab in combination with ivonescimab, as assessed by investigator, based on RECIST v1.1 To evaluate the safety and tolerability of tiragolumab in combination with ivonescimab

Being tested
Tiragolumab, Ivonescimab

What participants receive

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

  • TiragolumabDrug

    Given by IV

  • IvonescimabDrug

    Given by IV

Study groups in NCT07038915
Study groupRoleWhat they receive
Single ArmExperimentalTreatment with Tiragolumab + Ivonescimab
Receives: Drug: Tiragolumab; Drug: Ivonescimab

What is being measured

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

  1. Safety and adverse events (AEs).

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    Measured: Through study completion; an average of 1 year

Timeline

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

  1. First posted26 Jun 2025
  2. Study start28 Jul 2025
  3. Primary completion28 Jul 2025
  4. Study completion28 Jul 2025

Why it stopped: 0 participants

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07038915
Sponsor's protocol ID
2025-0406
Other IDs
NCI-2025-04492
Status last verified
Jul 2025
First submitted
18 Jun 2025
Last updated
5 Aug 2025
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 Tiragolumab and Ivonescimab in people with Lung Squamous Cell Carcinoma and Anti-PD1/PDL1 Antibody, run by M.D. Anderson Cancer Center.

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 0 inclusion and 51 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: withdrawn, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and adverse events (AEs). (time frame: Through study completion; an average of 1 year). 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 NCT07038915.

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 5 Aug 2025.

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