CompletedPhase 2NCT04880863
Official study title

NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment in Subjects With Checkpoint Inhibitor Pretreated Advanced or Metastatic NSCLC

Study summary

Phase 2a Open-Label, Multicenter Trial of Naptumomab Estafenatox (NAP), following Obinutuzumab Pretreatment, on Days -13 and -12. NAP will be administered on Days 1-4 of treatment cycles 1-6, followed by docetaxel on Day 5. Starting cycle 7, NAP at a higher dose will be administered on Day 1 only and docetaxel on Day 2, in 21 days treatment cycles. When NAP is administered as monotherapy and not earlier than cycle 7, NAP will be administered on Day 1 only and cycles will be of 28 days treatment cycle.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedNAP (Naptumomab estafenatox) and Docetaxel

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 3, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?11 U.S. locations

Locations may change over time.

Who runs it?NeoTX Therapeutics Ltd.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
NeoTX Therapeutics Ltd.
Interventions being studied
Drug: NAP (Naptumomab estafenatox); Drug: Docetaxel; Drug: Obinutuzumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Main 1. Subjects must be at least 18 years of age 2. Subjects must have histologically and/or cytologically confirmed NSCLC 3. Subjects must have incurable (advanced or metastatic) disease at the time of enrolment 4. Subjects must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 5. Subjects must provide signed informed consent prior to any study specific procedures that are not part of standard medical care. 6. Subjects must have measurable neoplastic disease based on the iRECIST criteria 7. 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). Main

Reasons someone may not be able to joinExclusion criteria
  • 1. Subjects with active infection requiring treatment within 3 days of C1D1. 2. Subjects with other active neoplastic disease requiring concurrent anti-neoplastic treatment 3. Subjects with known, suspected or documented parenchymal brain metastases unless treated with surgery and/or radiation, with the subject neurologically stable and off pharmacologic doses of systemic glucocorticoids; subjects with leptomeningeal metastases are not eligible. Patients should have completed brain radiation for at least 14 days and be off steroids. 4. Active or previously documented autoimmune or inflammatory disorders such as, but not limited to rheumatoid arthritis, systemic lupus erythematosus, uveitis, ulcerative colitis, Crohn's syndrome, Wegener's syndrome, multiple sclerosis, myasthenia gravis, scleroderma and sarcoidosis. The following are exceptions to this criterion:
  • Vitiligo or psoriasis not requiring systemic treatment (within the last 2 years)
  • Subjects with endocrinopathies (e.g. following Hashimoto syndrome) stable on hormone replacement or do not require any therapy. 5. History of primary immunodeficiency 6. Subjects with a history or prior allogeneic organ transplant

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • NeoTX - 10307Daphne, Alabama
  • NeoTX - 10302Scottsdale, Arizona
  • NeoTX - 10303Tucson, Arizona
  • NeoTX - 10306Lone Tree, Colorado
  • NeoTX - 10304Minneapolis, Minnesota
  • NeoTX - 10100Morristown, New Jersey
  • NeoTX - 10308Austin, Texas
  • NeoTX - 10309Dallas, Texas
  • NeoTX - 10312El Paso, Texas
  • NeoTX - 10310Tyler, Texas
  • NeoTX - 10311Fairfax, Virginia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 3, 2025. Always confirm current availability with the study team.

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