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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 have received as least 1 and no more than 2 prior systemic regimens for the treatment of advanced/metastatic NSCLC. Patients are required to have progressed following treatment with both platinum-based chemotherapy and an anti-PD-(L)1 antibody administered either sequentially or concurrently. A prior PD-1/PD-L1 inhibitor is, however, not required if there was prior exposure to targeted therapies for a driver mutation positive tumors (e.g. EGFR or ALK inhibitors)
Subjects must be at least 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up (estimated about 24 months).
Awards & highlights

NT-NAP-102-1 Trial Summary

This trial is testing a new cancer drug, NAP, to see if it is effective when used with the existing drug docetaxel. The trial will involve pretreating patients with obinutuzumab (another existing drug) before giving them the NAP/docetaxel combination. Treatment cycles will last 21 days.

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.Check my eligibility
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.See study design
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.

NT-NAP-102-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've had 1-2 treatments for advanced lung cancer and my cancer grew despite these treatments.
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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.

NT-NAP-102-1 Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Response (DOR)
NAP blood levels over time
+4 more

NT-NAP-102-1 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

Find a Location

Who is running the clinical trial?

NeoTX Therapeutics Ltd.Lead Sponsor
2 Previous Clinical Trials
90 Total Patients Enrolled
Translational Drug DevelopmentOTHER
18 Previous Clinical Trials
1,027 Total Patients Enrolled
Ilana Lorber, MDStudy DirectorNeoTX Therapeutics Ltd.
1 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

Docetaxel (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04880863 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: NAP in combination with docetaxel following obinutuzumab pretreatment
Non-Small Cell Lung Cancer Clinical Trial 2023: Docetaxel Highlights & Side Effects. Trial Name: NCT04880863 — Phase 2
Docetaxel (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04880863 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How widely distributed is this experiment across the United States?

"Participants for this medical trial may be enrolled at NeoTX- 10200 in Hartford, Connecticut, NeoTX - 10307 in Daphne, Alabama and NeoTX - 10100 in Morristown, New jersey or any of the additional 13 sites."

Answered by AI

What medical conditions are managed with NAP (Naptumomab estafenatox)?

"Naptumomab estafenatox (NAP) is utilized to treat malignant neoplasms, as well as advance directives, sarcoma, and refractory follicular lymphoma."

Answered by AI

Are there currently any open recruitment opportunities for this trial?

"According to clinicaltrials.gov, this research project is actively seeking participants and began advertising on October 26th 2021. The most recent update was logged August 25th 2022."

Answered by AI

What potential adverse effects could arise from NAP (Naptumomab estafenatox) treatment?

"There is some evidence that NAP (Naptumomab estafenatox) can be considered a safe medication, so it received an evaluation score of 2. This reflects the Phase 2 nature of this trial as there is data for safety but not yet efficacy."

Answered by AI

What is the total number of participants enrolled in this research project?

"This clinical trial necessitates 35 individuals that fulfill the criteria for enrolment. Eligible participants may enrol from NeoTX- 10200 in Hartford, Connecticut or NeoTX - 10307 in Daphne, Alabama."

Answered by AI

Have any further investigations been conducted using the drug NAP (Naptumomab estafenatox)?

"Currently, 419 separate studies centred around NAP (Naptumomab estafenatox) are happening in the world with 144 of these trials at Phase 3. There is a concentration of clinical studies taking place in Fuzhou, Fujian yet 27228 distinct locations have active research projects focusing on this drug."

Answered by AI
~11 spots leftby Mar 2025