A Safety and Tolerability Study of NC318 in Combination With Chemotherapy for Subjects With Advanced or Metastatic NSCLC

NCT04430933 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: NC318-02
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This research study is studying an investigational drug, NC318, as a possible treatment for subjects with advanced or metastatic non-small cell lung cancer in combination with chemotherapy

Conditions

Advanced or Metastatic Solid Tumors; Non-Small Cell Lung Cancer

Keywords

Advanced Cancer; NC318; Metastatic Cancer; Non-Small Cell Lung Cancer; NSCLC; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0

  Frequency, duration, and severity of treatment-emergent adverse events (AEs)

  14 months

Secondary Outcomes (6)

• Objective Response Rate per RECIST

  14 months

• Duration of Response per RECIST

  14 months

• Disease Control Rate per RECIST

  14 months

• Progression-Free Survival per RECIST

  14 months

• Overall Survival per RECIST

  14 months

Study Arms (3)

NC318 + Pemetrexed/Carboplatin

EXPERIMENTAL

NC318 at various dose strengths administered on the first day of each 21 day cycle in combination with pemetrexed/carboplatin

Drug: NC318; Drug: Pemetrexed/Carboplatin

NC318 + Nab-paclitaxel/carboplatin

EXPERIMENTAL

NC318 at various dose strengths administered on the first day of each 21 day cycle in combination with Nab-paclitaxel/carboplatin

Drug: NC318; Drug: Nab paclitaxel/Carboplatin

NC318 + Docetaxel

EXPERIMENTAL

NC318 at various dose strengths administered on the first day of each 21 day cycle in combination with Docetaxel

Drug: NC318; Drug: Docetaxel

Interventions

NC318 DRUG

NC318 is an experimental antibody drug that will be administered by IV infusion on the first day of each 21 day cycle

NC318 + Docetaxel; NC318 + Nab-paclitaxel/carboplatin; NC318 + Pemetrexed/Carboplatin

Pemetrexed/Carboplatin DRUG

Pemetrexed/Carboplatin will be administered per the approved respective product label following the infusion of NC318 on the first day of each 21 day cycle

NC318 + Pemetrexed/Carboplatin

Nab paclitaxel/Carboplatin DRUG

Nab-paclitaxel/Carboplatin will be administered per the approved respective product label following the infusion of NC318 on the first day of each 21 day cycle

NC318 + Nab-paclitaxel/carboplatin

Docetaxel DRUG

Docetaxel will be administered per the approved product label following the infusion of NC318 on the first day of each 21 day cycle

NC318 + Docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 18 or older.
• Willingness to provide written informed consent for the study.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
• Have a life expectancy of at least 6 months
• Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
• Disease progression after receipt of a prior systemic immunotherapy such as monoclonal antibodies targeting PD-1, PD-L1, CTLA-4 or other immune modulators with or without chemotherapy.
• Presence of measurable disease based on RECIST v1.1. Tumor lesions - situated in a previously irradiated area, or in an area subjected to other locoregional therapy, are not considered measurable unless there has been demonstrated progression in the lesion.
• After dose escalation, subject must be willing to undergo pretreatment and on-treatment tumor biopsies (core or excisional). Note: A baseline biopsy obtained for other purposes (i.e., not an NC318-02 study procedure) before signing consent may be utilized if the subject has not had any intervening systemic therapy from the time of the biopsy to the start of treatment with the medical monitor's approval.
• Female subjects of childbearing potential (defined as women who have not undergone surgical sterilization with a hysterectomy and/or bilateral oophorectomy and are not postmenopausal, defined as ≥ 12 months of amenorrhea) must have a negative serum pregnancy test at screening. All female and male subjects of childbearing potential must agree to take appropriate precautions to avoid pregnancy or fathering children (with at least 99% certainty) from screening through 60 days after the last dose of study drug.

You may not qualify if:

• Inability to comprehend or unwilling to sign the Informed Consent Form.
• Received more than 1 prior line of systemic anti-cancer therapy for Stage IIIB/IIIc/IV or recurrent NSCLC disease (does not include adjuvant or neoadjuvant treatments).
• Requires concurrent radiation or other anticancer therapy
• Screening laboratory values of:
• Absolute neutrophil count \< 1.5 × 10\^9/L
• Platelets \< 100 × 10\^9/L
• Hemoglobin \< 9 g/dL or \< 5.6 mmol/L
• Serum creatinine \> 1.5 × institutional upper limit of normal (ULN)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 2.5 × ULN
• Total bilirubin ≥ 1.5 × ULN unless conjugated bilirubin ≤ ULN (conjugated bilirubin only needs to be tested if total bilirubin exceeds ULN). If there is no institutional ULN, then direct bilirubin must be \< 40% of total bilirubin.
• International normalized ratio (INR) or prothrombin time (PT) \> 1.5 × ULN
• Activated partial thromboplastin time (aPTT) \> 1.5 × ULN
• Transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 14 days before the first administration of study drug.
• Receipt of anticancer medications or investigational drugs within the following intervals before the first administration of study drug:
• ≤ 21 days for chemotherapy or radiation therapy. Subjects must also not require chronic use of corticosteroids and must not have had radiation pneumonitis because of a treatment. A 1-week washout is permitted for palliative radiation to non-central nervous system (CNS) disease with medical monitor approval. Note: Bisphosphonates and denosumab are permitted medications.

Sponsors & Collaborators

• NextCure, Inc.: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis

Interventions

Pemetrexed; Carboplatin; Taxes; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals; Economics; Health Care Economics and Organizations; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Sol Langermann, PhD

  NextCure, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 16, 2020
• Study Start: December 6, 2021
• Primary Completion: June 30, 2022
• Study Completion: October 30, 2022
• Last Updated: August 18, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share