What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, antiangiogenic therapy, and immune checkpoint inhibitors. Chemotherapy often causes side effects such as fatigue, nausea, vomiting, hair loss, and increased risk of infection. Antiangiogenic therapies, which inhibit blood vessel growth in tumors, can lead to hypertension, bleeding, and thromboembolic events. Immune checkpoint inhibitors, like pembrolizumab and atezolizumab, can cause immune-related adverse events including colitis, pneumonitis, hepatitis, and endocrinopathies. These treatments aim to target tumor growth and proliferation, similar to the investigational agent QEQ278.

What prior FDA approvals exist?

Several FDA-approved treatments for Non-Small Cell Lung Cancer (NSCLC) target tumor growth and proliferation. Pembrolizumab, an anti-PD-1 therapy, has shown significant improvement in overall survival and progression-free survival when combined with chemotherapy in patients with advanced NSCLC. Atezolizumab, another immune checkpoint inhibitor targeting PD-L1, is approved in combination with chemotherapy and bevacizumab for patients without EGFR or ALK mutations. Additionally, nivolumab, often combined with ipilimumab, is approved for patients with PD-L1 expression. These therapies work by enhancing the immune system's ability to target and destroy cancer cells, thereby inhibiting tumor growth and proliferation.

What other types of research exist?

Promising novel alternatives to QEQ278 for NSCLC patients include: 1) WK88-1, an Hsp90 inhibitor that suppresses growth in gefitinib-resistant NSCLC with the T790M mutation. 2) YH25448, a third-generation EGFR-TKI with potent systemic and intracranial activity in EGFR T790M mutated NSCLC. 3) Pembrolizumab, a PD-1 inhibitor, which has shown efficacy in patients with advanced NSCLC, particularly those with PD-L1 expression.

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QEQ278 for Cancer

Phase 1

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

HPV-associated head and neck squamous cell carcinoma

Must not have

Patients with a history of or current interstitial lung disease or pneumonitis ≥ Grade 2.

Any serious uncontrolled infection (acute or chronic).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 31 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called QEQ278 in adults with advanced cancers that are hard to treat. Researchers aim to find out if the drug is safe and if it can help shrink tumors.

Who is the study for?

Adults over 18 with advanced cancers like non-small cell lung, renal cell, esophageal squamous cell carcinoma, or HPV-related head and neck cancer. Participants must have measurable disease, be unresponsive to standard treatments or ineligible for them, and willing to undergo tumor biopsies. Exclusions include those with tuberculosis history, poor bone marrow function, serious infections including COVID-19, significant cardiac issues or a history of severe reactions to anti-PD-1 therapy.

What is being tested?

The trial is testing the safety and effects of QEQ278 when given intravenously to patients with certain advanced solid tumors. It will assess how the body processes the drug (pharmacokinetics), its impact on the body (pharmacodynamics), tolerability at different doses and preliminary effectiveness in shrinking tumors.

What are the potential side effects?

While specific side effects are not listed here for QEQ278 as it's under investigation, common side effects for similar cancer therapies may include fatigue, nausea, inflammation at injection sites and potential immune-related responses that could affect various organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is advanced, cannot be cured by surgery or radiation, and has at least one measurable lesion.

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My cancer in the head or neck is linked to HPV.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have never had severe lung inflammation.

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I do not have any serious uncontrolled infections.

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I have heart problems or risk factors for heart disease.

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I am not on high-dose steroids or immunosuppressants, except for low-dose replacement therapy.

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I have a history of tuberculosis.

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My bone marrow is not working well.

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I currently have a confirmed case of COVID-19.

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I stopped anti-PD-1 therapy because of its side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 31 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 31 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 31 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose intensity

Frequency of dose interruptions, reductions

Incidence and nature of Dose Limiting Toxicities (DLTs) during the DLT evaluation period for single agent QEQ278

+1 more

Secondary study objectives

Area under the concentration time curve (AUC) infinity of QEQ278

Area under the concentration time curve (AUC) last of QEQ278

Disease control rate (DCR) per RECIST v1.1

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2: Dose expansionExperimental Treatment1 Intervention

Dose expansion with QEQ278 single agent

Group II: Part 1: Dose escalationExperimental Treatment1 Intervention

Dose escalation with QEQ278 single agent

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include immune checkpoint inhibitors, chemotherapy, and targeted therapies. Immune checkpoint inhibitors, such as pembrolizumab and nivolumab, work by blocking proteins like PD-1/PD-L1, which cancer cells use to evade the immune system, thereby enhancing the body's ability to fight cancer. Chemotherapy drugs, such as cisplatin and docetaxel, kill rapidly dividing cells, including cancer cells, but also affect normal cells, leading to side effects. Targeted therapies, like those inhibiting EGFR or ALK, specifically target genetic mutations or proteins involved in cancer cell growth and survival, offering a more personalized treatment approach. These mechanisms are crucial for NSCLC patients as they provide multiple strategies to combat the disease, potentially improving survival rates and quality of life.