Ivonescimab + Chemotherapy for NSCLC

Not yet recruiting at 2 trial locations
JJ
Overseen ByJessica J. Lin, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Massachusetts General Hospital
Must be taking: Targeted therapies
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ivonescimab for individuals with advanced non-small cell lung cancer (NSCLC). The researchers aim to determine if ivonescimab, alone or with chemotherapy, can shrink tumors and improve survival. Participants should have NSCLC with specific genetic alterations and have previously tried targeted therapies, with or without chemotherapy, depending on the trial group. Those with prior lung cancer treatments and specific genetic changes in their cancer might be eligible. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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

The trial information does not specify if you need to stop taking your current medications. However, if you are on certain medications like corticosteroids or anticoagulants, you may need to adjust your dosage or ensure stability before joining. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that ivonescimab, when used alone, can cause side effects such as low white blood cell count, nausea, diarrhea, low red blood cell count, hair loss, and tiredness. These side effects are manageable and often resemble those of other cancer treatments.

When combined with chemotherapy, studies have found ivonescimab to be generally safe, with a safety profile similar to other treatments. Patients in these studies experienced side effects like low blood counts and tiredness, which are expected with chemotherapy.

Overall, ivonescimab, whether used alone or with chemotherapy, has been well-tolerated in past studies. As research continues, more information will become available.12345

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for non-small cell lung cancer (NSCLC), which mainly include targeted therapies, chemotherapy, and immune checkpoint inhibitors, Ivonescimab is unique because it combines targeted therapy with immune modulation. Researchers are excited about Ivonescimab because it targets specific genomic alterations in cancer cells and also enhances the immune system's ability to attack the cancer. This dual action could potentially improve treatment outcomes for patients who have progressed after standard therapies. Additionally, Ivonescimab, when combined with chemotherapy agents like carboplatin and pemetrexed, might bolster the effectiveness of these traditional treatments, offering a new hope for patients with advanced NSCLC.

What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?

Research has shown that ivonescimab, one of the treatments in this trial, holds promise for treating advanced non-small cell lung cancer (NSCLC). Participants may receive ivonescimab alone or with chemotherapy drugs carboplatin and pemetrexed. Studies have found that ivonescimab can significantly slow cancer growth. When combined with carboplatin and pemetrexed, ivonescimab has helped patients live longer without their cancer worsening, even after previous treatments. Additionally, ivonescimab has a good safety profile, causing few severe side effects. These findings suggest that ivonescimab could be a valuable option for NSCLC patients seeking new treatments.13467

Who Is on the Research Team?

JJ

Jessics J Lin, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

Adults (18+) with advanced non-squamous NSCLC, specific genomic alterations, and prior targeted therapy can join. Those for ivonescimab monotherapy must have had platinum/pemetrexed chemo; those for the combo treatment shouldn't have had chemo but must've tried certain TKIs. Participants need a measurable tumor, may have stable brain metastases, good performance status (ECOG 0 or 1), and adequate organ function.

Inclusion Criteria

Ivonescimab monotherapy: Tumor harboring classical EGFR sensitizing mutation (i.e., L858R, exon 19 deletion), or ALK, ROS1, RET, or NTRK1-3 fusion, per local testing. Note: The number of patients with EGFR mutation-positive NSCLC enrolled will be capped at maximum of 10 (in order to ensure the assessment of non-EGFR disease subsets). Ivonescimab plus carboplatin/pemetrexed: Tumor harboring ALK, ROS1, RET, or NTRK1-3 fusion, per local testing.
I am 18 years old or older.
I can carry out all my usual activities without help.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ivonescimab monotherapy or ivonescimab with carboplatin/pemetrexed chemotherapy every 3 weeks

Up to 24 months
Every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Carboplatin
  • Ivonescimab
  • Pemetrexed

Trial Overview

The trial is testing if ivonescimab alone or combined with carboplatin/pemetrexed chemotherapy can shrink tumors in NSCLC patients with certain genomic changes. It looks at cancer progression, response duration, time to effect onset, disease control period, and overall survival rates.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Ivonescimab plus Carboplatin/PemetrexedExperimental Treatment3 Interventions
Group II: Ivonescimab MonotherapyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Summit Therapeutics

Industry Sponsor

Trials
18
Recruited
4,500+

Citations

Improved Outcomes Reported With Second-Line Regimen ...

... non–small cell lung cancer (NSCLC) had a significant delay in disease progression.1 Ivonescimab is an investigational, humanized ...

Efficacy and safety of ivonescimab in non-small cell lung cancer

Since the OS data of most studies are not yet mature, therefore, outcomes of interest included PFS, ORR, disease control rate (DCR), and the incidence of AEs.

First-line ivonescimab plus chemo improves PFS in squamous ...

First-line ivonescimab plus chemotherapy improves progression-free survival in squamous NSCLC ... “Squamous non-small cell lung cancer (NSCLC) ...

Ivonescimab Plus Chemo After Third-Generation TKI ...

Ivonescimab plus carboplatin/pemetrexed significantly improved PFS in EGFR-mutated NSCLC patients post-third-generation TKI therapy, with a ...

Ivonescimab improves survival in advanced non-small cell ...

1. Patients in the ivonescimab group demonstrated a significantly greater progression-free survival than those in the pembrolizumab group.

Ivonescimab Plus Chemotherapy Improves Progression ...

Ivonescimab Plus Chemotherapy Improves Progression-Free Survival in Patients with EGFR+ NSCLC Following 3rd-Generation EGFR-TKI Therapy. Press ...

Ivonescimab in Combination with Chemotherapy ...

In patients with up to 63% central squamous carcinoma, ivonescimab demonstrated a safety profile comparable to the control group. This ...