What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC), particularly those involving immunotherapy and chemotherapy, have a range of side effects. Immunotherapy agents such as pembrolizumab and atezolizumab can cause fatigue, rash, diarrhea, and immune-related adverse events like pneumonitis, colitis, and hepatitis. Chemotherapy agents like docetaxel, often used in combination with immunotherapy, can lead to neutropenia, anemia, fatigue, nausea, and neuropathy. The severity and frequency of these side effects can vary among patients.

What prior FDA approvals exist?

Several immunotherapies and targeted therapies have been approved by the FDA for the treatment of Non-Small Cell Lung Cancer (NSCLC). These include immune checkpoint inhibitors such as pembrolizumab, nivolumab, and atezolizumab, which target PD-1/PD-L1 pathways to enhance the immune system's ability to fight cancer. Additionally, targeted therapies like osimertinib for EGFR mutations, crizotinib for ALK rearrangements, and larotrectinib for NTRK fusions have been approved. These treatments, while not identical to Naptumomab Estafenatox, share the common goal of targeting specific antigens or pathways to improve patient outcomes in NSCLC.

What other types of research exist?

Promising, novel alternatives to Naptumomab Estafenatox for NSCLC patients include: 1) NFV (an HIV-1 protease inhibitor) which induces growth arrest, reduces Akt signaling, and enhances docetaxel sensitivity in NSCLC cell lines. 2) Talniflumate, a GCNT3 inhibitor, which has shown to reduce colony formation and migration in NSCLC models. These alternatives have demonstrated significant preclinical activity and could be considered for further clinical evaluation.

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Chemotherapy

NAP + Docetaxel for Lung Cancer (NT-NAP-102-1 Trial)

Phase 2

Waitlist Available

Research Sponsored by NeoTX Therapeutics Ltd.

Eligibility Criteria Checklist

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

Must have

Subjects must be at least 18 years of age

Subjects must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Must not have

Subjects with other active neoplastic disease requiring concurrent anti-neoplastic treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up (estimated about 24 months).

Awards & highlights

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial is testing a new drug combination for cancer patients who need alternative treatments. It starts with a preparation phase using a specific drug, followed by another drug to target cancer cells and a third drug to stop their growth. The third drug has shown effectiveness in treating various tumors and is the first with proven efficacy against prostate cancer.

Who is the study for?

Adults with advanced or metastatic NSCLC who've had up to two prior treatments, including platinum-based chemo and anti-PD-(L)1 antibodies (or targeted therapies for specific mutations), can join. They must have measurable cancer per iRECIST criteria, be in good physical condition (ECOG 0-1), and not have active infections, other cancers needing treatment, brain metastases unless stable post-treatment, autoimmune diseases except certain exceptions like treated vitiligo or stable endocrinopathies.

What is being tested?

The trial tests Naptumomab Estafenatox (NAP) combined with Docetaxel after Obinutuzumab pretreatment in NSCLC patients previously treated with checkpoint inhibitors. Initially, NAP is given on days 1-4 followed by Docetaxel on day 5 for six cycles; then from cycle seven onwards, the dose of NAP increases and is administered alone every four weeks.

What are the potential side effects?

Potential side effects include reactions related to immune activation such as inflammation in various organs due to NAP's mechanism of action. Docetaxel may cause hair loss, nausea/vomiting, low blood cell counts leading to infection risk or bleeding problems. Obinutuzumab might lead to infusion reactions and increased vulnerability to infections.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My lung cancer diagnosis was confirmed through lab tests.

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My disease is advanced and cannot be cured.

Exclusion Criteria

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

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I am currently receiving treatment for another cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ (estimated about 24 months).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~(estimated about 24 months).

This trial's timeline: 3 weeks for screening, Varies for treatment, and (estimated about 24 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

Objective Response Rate (ORR)

Secondary study objectives

Disease Control Rate (DCR)

Duration of Response (DOR)

NAP blood levels over time

+4 more

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: NAP in combination with docetaxel following obinutuzumab pretreatmentExperimental Treatment3 Interventions

Subjects will receive obinutuzumab, 1,000 mg, administered by IV infusion on Days -13 and -12 of the first treatment cycle in order to reduce the titer of anti-drug antibodies to NAP. NAP will be administered in a daily dose of 10 μg/kg by IV bolus on Days 1 - 4 of treatment cycles 1-6, followed by docetaxel, 75 mg/m2 on Day 5. Treatment cycles with the combination NAP/docetaxel will be 21 days in duration. Starting cycle 7, NAP at a higher dose of 15 μg/kg will be administered on Day 1 and docetaxel on Day 2, in 21 days treatment cycles. Once NAP is given as monotherapy and not earlier than C7, cycles will be of 28 days of duration.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Naptumomab estafenatox

Not yet FDA approved

Docetaxel

FDA approved

Obinutuzumab

FDA approved

0 / 5Eligibility 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 targeted therapies and immunotherapies. Targeted therapies, such as EGFR and ALK inhibitors, block specific molecular pathways essential for cancer cell growth. Immunotherapies, like PD-1/PD-L1 inhibitors, enhance the immune system's ability to detect and kill cancer cells. Naptumomab Estafenatox, which targets the 5T4 antigen on tumor cells and activates T cells, exemplifies a treatment that combines targeted therapy with immune activation. This dual approach is crucial for NSCLC patients as it provides a more focused attack on cancer cells while also stimulating the immune system, potentially improving treatment efficacy and patient outcomes.