Carcinoma, Non-Small-Cell LungPhase 1NCT05462873
A Study to Investigate the Safety and Tolerability of Intravenous QEQ278 in Patients With Advanced Solid Tumors
A Phase 1 study testing QEQ278 in people with Carcinoma, Non-Small-Cell Lung and Carcinoma, Renal Cell, run by Novartis Pharmaceuticals at 12 sites in 9 countries.
Trial summary
To characterize safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of QEQ278 in adult patients with advanced/metastatic non-small cell lung cancer, esophageal squamous cell carcinoma, renal cell carcinoma, and human papilloma virus associated head and neck squamous cell… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Esophageal Squamous Cell Carcinoma
- What is being tested?
- QEQ278
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 12 sitesin 9 countries
- Study dates
- 4 Apr 2023to 26 Jan 2026
- Phase
- Phase 1
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent must be obtained prior to participation in the study.
- Adult men and women ≥ 18 years of age.
- Histologically confirmed and documented advanced malignancies (locally advanced malignancies, non-curable by surgery or radiotherapy and metastatic disease). Disease must be measurable, including presence of at least one measurable lesion, as determined by RECIST v1.1.
- In the opinion of the treating investigator, patients must have received, but are not benefitting from standard therapies, be intolerant or ineligible to receive such therapy, or have no standard therapy option for the respective disease types (diseases listed below), as well as any other therapies deemed to be standard by local/institutional standard.
- Non-small cell lung cancer
- Esophageal squamous cell carcinoma
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- Renal cell carcinoma
- HPV-associated head and neck squamous cell carcinoma
- Must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines. The patient must be willing to undergo a new tumor biopsy at screening and during treatment.
Who cannot join
- Active previously documented or suspected autoimmune disease. Patients with vitiligo, type I diabetes, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur should not be excluded. Patients previously exposed to anti-PD-1/PD-L1 treatment who are adequately treated for skin rash or with replacement therapy for endocrinopathies should not be excluded.
- Patients with a history of or current interstitial lung disease or pneumonitis ≥ Grade 2.
- Patients who discontinued prior anti-PD-1 therapy due to an anti-PD-1-related toxicity
- Clinically significant cardiac disease or risk factors at screening
- Insufficient bone marrow function at screening:
- Infections:
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- Known history of testing positive for Human Immunodeficiency Virus infection.
- Active Hepatitis B and / or Hepatitis C.
- Active, documented COVID-19 infection
- Known history of tuberculosis
- Any serious uncontrolled infection (acute or chronic).
- Systemic chronic steroid therapy (>10 mg/day prednisone or equivalent) or any immunosuppressive therapy, other than replacement-dose steroids in the setting of adrenal insufficiency, within 7 days of the first dose of study treatment. Topical, inhaled, and ophthalmic steroids are allowed.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
12 sites in 9 countries.
12 sites in 9 countries
United States4 sites
Massachusetts General Hospital Dept. of Mass General Hospital
Boston, Massachusetts, 02114
Massachusetts General Hospital
Boston, Massachusetts, 02114
Florida Cancer Specialists
Fort Myers, Florida, 33901
University of California LA
Los Angeles, California, 90095
About this study
Official title: A Phase I/Ib, Open-label, Multi-center, Study of QEQ278 in Patients With Advanced Solid Tumors
To characterize safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of QEQ278 in adult patients with advanced/metastatic non-small cell lung cancer, esophageal squamous cell carcinoma, renal cell carcinoma, and human papilloma virus associated head and neck squamous cell carcinoma.
Read the detailed description
This study is an open-label, phase I/Ib, multi-center study of QEQ278 as a single agent, consisting of a dose escalation part followed by a dose expansion part.
In the dose escalation part of the study, patients with non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), renal cell carcinoma (RCC), or human papilloma virus (HPV)-associated head and neck squamous cell carcinoma (HNSCC) will be treated with QEQ278 single agent until the maximum tolerated dose (MTD) is reached or a lower recommended dose (RD) is established.
The study may enter the dose expansion, after an MTD(s) and/or RD(s) is declared in the dose escalation.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Esophageal Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck
- Being tested
- QEQ278
- Keywords
- NKG2D, NKG2D-L, immunotherapy, ADCC, NK cells, NSCLC, ESCC, RCC, HPV-associated HNSCC, QEQ278
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Esophageal Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QEQ278Biological
Intravenous dosing of QEQ278
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose escalation | Experimental | Dose escalation with QEQ278 single agent Receives: Biological: QEQ278 |
| Part 2: Dose expansion | Experimental | Dose expansion with QEQ278 single agent Receives: Biological: QEQ278 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and nature of Dose Limiting Toxicities (DLTs) during the DLT evaluation period for single agent QEQ278
A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the DLT evaluation period and meets the criteria defined in the study protocol.
Measured: 28 days
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), including changes in laboratory values, vital signs, and electrocardiograms (ECGs) qualifying and reported as AEs.
Measured: Up to 31 months
Frequency of dose interruptions, reductions
Number of dose interruptions of QEQ278 and number of dose reductions of QEQ278
Measured: Up to 30 months
Dose intensity
Dose intensity of QEQ278 is defined as the ratio of actual cumulative dose received and actual duration of exposure.
Measured: Up to 30 months
Secondary outcomes (12)
Overall response rate (ORR) per RECIST v1.1
ORR is defined as the proportion of patients with a confirmed BOR of complete response (CR) or partial response (PR) by local investigator review as per RECIST v1.1.
Measured: Up to 30 months
Disease control rate (DCR) per RECIST v1.1
DCR is defined as the proportion of patients with a confirmed best overall response (BOR) of CR or PR or stable disease (SD) by local investigator review as per RECIST v1.1.
Measured: Up to 30 months
Duration of Response (DOR) per RECIST v1.1
DOR is defined as the time form the date of the first documented response (CR or PR) to the date of the first documented progression by local investigator review as per RECIST v1.1 or death due to underlying cancer.
Measured: Up to 30 months
Progression-free survival (PFS) per RECIST v 1.1
PFS is defined as the time from the date of start of treatment to the date of the first documented progression by local investigator review as per RECIST v1.1, or death due to any cause.
Measured: Up to 30 months
Peak serum concentration (Cmax) of QEQ278
The maximum (peak) serum drug concentration after single dose administration
Measured: During first 168 days of treatment
Area under the concentration time curve (AUC) last of QEQ278
The AUC from time zero to the last measurable concentration sampling time
Measured: During first 168 days of treatment
Area under the concentration time curve (AUC) infinity of QEQ278
The AUC from time zero to infinity
Measured: During first 168 days of treatment
Time to reach peak serum concentration (Tmax) of QEQ278
The time to reach maximum (peak) serum drug concentration after single dose administration
Measured: During first 168 days of treatment
Elimination half-life (T1/2) of QEQ278
The elimination half-life associated with the terminal slope of a semi logarithmic concentration-time curve
Measured: During first 168 days of treatment
Total body clearance (CL) of QEQ278
The total body clearance of drug from the serum
Measured: During first 168 days of treatment
Volume of distribution (Vz) of QEQ278
The apparent volume of distribution during terminal phase
Measured: During first 168 days of treatment
Incidence of anti-drug antibody (ADA)
Immunogenicity of QEQ278
Measured: Day 1 and 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start4 Apr 2023
- Primary completion26 Jan 2026
- Study completion26 Jan 2026
Why it stopped: Business decision and not related to safety concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462873
- Sponsor's protocol ID
- CQEQ278A12101
- Status last verified
- Feb 2026
- First submitted
- 14 Jul 2022
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/Ib, Open-label, Multi-center, Study of QEQ278 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05462873
- Acronym / sponsor ID
- CQEQ278A12101
- Conditions
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Esophageal Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck
- Keywords
- NKG2D, NKG2D-L, immunotherapy, ADCC, NK cells, NSCLC, ESCC, RCC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision and not related to safety concerns
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 26 Jan 2026 (actual)
- Study completion
- 26 Jan 2026 (actual)
- First posted
- 18 Jul 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.
To characterize safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of QEQ278 in adult patients with advanced/metastatic non-small cell lung cancer, esophageal squamous cell carcinoma, renal cell carcinoma, and human papilloma virus associated head and neck squamous cell carcinoma.
Detailed description
This study is an open-label, phase I/Ib, multi-center study of QEQ278 as a single agent, consisting of a dose escalation part followed by a dose expansion part.
In the dose escalation part of the study, patients with non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), renal cell carcinoma (RCC), or human papilloma virus (HPV)-associated head and neck squamous cell carcinoma (HNSCC) will be treated with QEQ278 single agent until the maximum tolerated dose (MTD) is reached or a lower recommended dose (RD) is established.
The study may enter the dose expansion, after an MTD(s) and/or RD(s) is declared in the dose escalation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose escalation | Experimental | Biological: QEQ278Dose escalation with QEQ278 single agent |
| Part 2: Dose expansion | Experimental | Biological: QEQ278Dose expansion with QEQ278 single agent |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed informed consent must be obtained prior to participation in the study.
- Adult men and women ≥ 18 years of age.
- Histologically confirmed and documented advanced malignancies (locally advanced malignancies, non-curable by surgery or radiotherapy and metastatic disease). Disease must be measurable, including presence of at least one measurable lesion, as determined by RECIST v1.1.
- In the opinion of the treating investigator, patients must have received, but are not benefitting from standard therapies, be intolerant or ineligible to receive such therapy, or have no standard therapy option for the respective disease types (diseases listed below), as well as any other therapies deemed to be standard by local/institutional standard.
- Non-small cell lung cancer
Key exclusion criteria (13 listed)
- Active previously documented or suspected autoimmune disease. Patients with vitiligo, type I diabetes, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur should not be excluded. Patients previously exposed to anti-PD-1/PD-L1 treatment who are adequately treated for skin rash or with replacement therapy for endocrinopathies should not be excluded.
- Patients with a history of or current interstitial lung disease or pneumonitis ≥ Grade 2.
- Patients who discontinued prior anti-PD-1 therapy due to an anti-PD-1-related toxicity
- Clinically significant cardiac disease or risk factors at screening
- Insufficient bone marrow function at screening:
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 |
|---|---|---|
| QEQ278Intravenous dosing of QEQ278 | Biological | Part 1: Dose escalation, Part 2: Dose expansion |
Primary outcome
Incidence and nature of Dose Limiting Toxicities (DLTs) during the DLT evaluation period for single agent QEQ278
Time frame: 28 days
A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the DLT evaluation period and meets the criteria defined in the study protocol.
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to 31 months
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), including changes in laboratory values, vital signs, and electrocardiograms (ECGs) qualifying and reported as AEs.
Frequency of dose interruptions, reductions
Time frame: Up to 30 months
Number of dose interruptions of QEQ278 and number of dose reductions of QEQ278
Dose intensity
Time frame: Up to 30 months
Dose intensity of QEQ278 is defined as the ratio of actual cumulative dose received and actual duration of exposure.
12 secondary outcomes
Overall response rate (ORR) per RECIST v1.1
Time frame: Up to 30 months
Disease control rate (DCR) per RECIST v1.1
Time frame: Up to 30 months
Duration of Response (DOR) per RECIST v1.1
Time frame: Up to 30 months
Progression-free survival (PFS) per RECIST v 1.1
Time frame: Up to 30 months
Peak serum concentration (Cmax) of QEQ278
Time frame: During first 168 days of treatment
Area under the concentration time curve (AUC) last of QEQ278
Time frame: During first 168 days of treatment
Area under the concentration time curve (AUC) infinity of QEQ278
Time frame: During first 168 days of treatment
Time to reach peak serum concentration (Tmax) of QEQ278
Time frame: During first 168 days of treatment
Elimination half-life (T1/2) of QEQ278
Time frame: During first 168 days of treatment
Total body clearance (CL) of QEQ278
Time frame: During first 168 days of treatment
Volume of distribution (Vz) of QEQ278
Time frame: During first 168 days of treatment
Incidence of anti-drug antibody (ADA)
Time frame: Day 1 and 15
Results and safety
The study was stopped early (reason given: Business decision and not related to safety concerns). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QEQ278 in people with Carcinoma, Non-Small-Cell Lung and Carcinoma, Renal Cell, run by Novartis Pharmaceuticals at 12 sites in 9 countries.
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 9 inclusion and 13 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: stopped early, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Belgium, France, Germany, Italy and 4 more countries. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 stopped early (reason given: Business decision and not related to safety concerns). Results are not available in the source record.
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?
Incidence and nature of Dose Limiting Toxicities (DLTs) during the DLT evaluation period for single agent QEQ278 (time frame: 28 days). The study lists 4 primary outcomes in all. 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 17 Feb 2026.