NXP900 + Osimertinib for Non-Small Cell Lung Cancer

Recruiting at 2 trial locations

Overseen By Shay Shemesh

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Nuvectis Pharma, Inc.

Must be taking: Osimertinib

Disqualifiers: Other oncogenic drivers, HER2 overexpression

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, NXP900 (an experimental treatment), combined with an existing drug, osimertinib, to determine its effectiveness for people with non-small cell lung cancer (NSCLC) that has specific genetic changes and has progressed despite treatment. The main goal is to identify the best dose of NXP900 when used with osimertinib. This trial suits those with advanced NSCLC with EGFR mutations who have already tried osimertinib, either alone or with chemotherapy, but the cancer has continued to grow. Participants will receive varying doses of NXP900 to determine the most effective and safest amount. As a Phase 1 trial, this research focuses on understanding how NXP900 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, since the trial involves osimertinib, you may need to continue taking it if you are already on it.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that the combination of NXP900 and osimertinib is under study to determine its safety and effectiveness for treating advanced non-small cell lung cancer (NSCLC) with specific genetic changes. Lab studies conducted before human testing showed promising results for this combination.

As this study is in an early stage, researchers are closely monitoring how participants tolerate NXP900 with osimertinib, including any unwanted side effects. While the safety of using these treatments together remains under investigation, it is important to note that osimertinib is already approved for some lung cancer patients, indicating its safety is well understood. However, NXP900 is still undergoing testing.

Participation in the study will help researchers gain more insight into the safety and effectiveness of this new treatment combination. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

NXP900 is unique because it works alongside osimertinib to potentially enhance treatment effectiveness for non-small cell lung cancer. While standard treatments like chemotherapy and targeted therapies focus on different pathways, NXP900's novel approach involves escalating doses that are designed to optimize its effects when combined with osimertinib, a well-established EGFR inhibitor. Researchers are excited because this combination could offer a more potent attack on cancer cells by targeting multiple mechanisms, potentially improving outcomes for patients with this aggressive cancer.

What evidence suggests that NXP900 in combination with osimertinib could be effective for non-small cell lung cancer?

In this trial, participants will receive escalating doses of NXP900 combined with osimertinib. Studies have shown that this combination holds promise for treating advanced non-small cell lung cancer (NSCLC) with specific genetic changes called EGFR mutations. Research suggests that this combination outperforms osimertinib alone, potentially increasing treatment effectiveness. Osimertinib already benefits patients with this cancer type, and adding NXP900 might enhance these results. The idea is that NXP900 could boost osimertinib's cancer-fighting ability. Early findings like these can encourage those considering joining a clinical trial. ^{1 2 3 5 6}

Who Is on the Research Team?

Zofia Piotrowska, MD, MHS

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

Adults over 18 with advanced, EGFR-mutated non-small cell lung cancer that can't be removed by surgery. Participants must have had previous treatment with osimertinib alone or with chemo and be in good physical condition (ECOG 0-1). They need to give written consent to join.

Inclusion Criteria

I have signed a consent form.

I am 18 years old or older.

I am fully active or can carry out light work.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Exploration

Escalating doses of NXP900 given with osimertinib

Up to approximately 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NXP900

Trial Overview

The trial is testing a new combination of drugs: NXP900 and Osimertinib, for people whose lung cancer has worsened despite earlier treatments. It's an early-phase study where everyone gets the same treatment to see how well it works and what side effects there are.

How Is the Trial Designed?

Group I: Dose Exploration (Part 1) Experimental Treatment 2 Interventions

Escalating doses of NXP900 given with osimertinib

Who Is Running the Clinical Trial?

Nuvectis Pharma, Inc.

Lead Sponsor

Trials

2

Recruited

100+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07315113

Study of NXP900 With Osimertinib in Subjects ...

Study of NXP900 With Osimertinib in Subjects With Advanced, EGFR-Mutated Non-Small Cell Lung Cancer · Study Overview · Contacts and Locations.

2.

biospace.com

biospace.com/press-releases/nuvectis-pharma-announces-the-initiation-of-the-phase-1b-study-of-nxp900-in-combination-with-osimertinib-in-patients-with-nsclc

Nuvectis Pharma Announces the Initiation of the Phase 1b ...

The study is designed to evaluate the safety and clinical activity of NXP900 in combination with osimertinib in patients with epidermal ...

3.

clinicaltrialvanguard.com

clinicaltrialvanguard.com/news/nuvectis-pharma-combination-therapy-improves-egfr-inhibitor-efficacy/

Nuvectis Pharma: Combination Therapy Improves EGFR ...

The research, conducted at the Lerner Research Institute, Cleveland Clinic, showed the combination therapy outperformed osimertinib alone in ...

4.

onco-this-week.com

onco-this-week.com/ph-1b-study-of-nxp900-osimertinib-combo-in-nsclc-patients-initiated/

Ph 1b Study of NXP900 + Osimertinib combo in NSCLC ...

Bentsur added, “The clinical benefit and improved outcomes afforded by osimertinib to patients with EGFRmut+ NSCLC are well known, and we ...

5.

firstwordpharma.com

firstwordpharma.com/story/5939716

Nuvectis Pharma Announces a New Publication of a ...

Nuvectis Pharma Announces a New Publication of a Research Study Demonstrating that the Combination of NXP900 and EGFR Inhibitors Improves the ...

6.

globenewswire.com

globenewswire.com/news-release/2025/12/17/3206848/0/en/Nuvectis-Pharma-Announces-the-Initiation-of-the-Phase-1b-Study-of-NXP900-in-Combination-with-Osimertinib-in-Patients-with-NSCLC.html

Nuvectis Pharma Announces the Initiation of the Phase 1b

The study is designed to evaluate the safety and clinical activity of NXP900 in combination with osimertinib in patients with epidermal ...