240 Participants Needed

Rina-S for Lung Cancer

(RAINFOL-05 Trial)

Recruiting at 1 trial location
GT
Overseen ByGenmab Trial Information
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 drug called Rina-S to evaluate its effectiveness against lung cancer, specifically adenocarcinoma. All participants will receive the actual drug, not a placebo, for about 12 months, with regular clinic visits for monitoring. The trial targets individuals whose lung cancer has worsened despite previous treatments and is not suitable for surgery or radiation. Participants should have measurable disease and be able to perform daily activities with minimal assistance. The trial aims to determine if Rina-S can stop or slow lung cancer growth. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that Rina-S is likely to be safe for humans?

Research has shown that Rina-S, the treatment being tested in the trial, has promising safety results from earlier studies. In one study, researchers tested Rina-S on patients with solid tumors, focusing on its safety and any side effects. The results suggested that Rina-S has a consistent safety record.

Importantly, some studies have found that patients did not experience serious side effects like eye damage or lung inflammation. However, reports of other side effects, such as nerve damage, exist, so participants should be aware of this possibility.

Overall, findings so far suggest that Rina-S is generally well-tolerated, with specific side effects that researchers are monitoring closely. This information helps potential participants understand what to expect regarding the safety of Rina-S in the ongoing trial.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for lung cancer, which often include chemotherapy, radiation, and targeted therapies, Rina-S acts as a monotherapy with a unique mechanism. Researchers are excited about Rina-S because it targets specific pathways in cancer cells that aren't addressed by the current treatment options. This innovative approach has the potential to be more effective for certain patients and may offer fewer side effects, making it a promising alternative in the fight against lung cancer.

What evidence suggests that Rina-S might be an effective treatment for lung cancer?

Research shows that Rina-S, the investigational treatment studied in this trial, holds promise in fighting tumors, especially for patients who have tried many treatments before. Studies have found that Rina-S is effective against lung cancer cells, particularly the common and challenging type known as non-small cell lung cancer (NSCLC). This treatment targets cancer cells while sparing healthy ones, potentially leading to better patient outcomes. Early findings suggest that Rina-S can slow tumor growth and may even shrink tumors in some cases. Its potential success stems from its ability to target and disrupt cancer cell functions.12367

Who Is on the Research Team?

SO

Study Official

Principal Investigator

Genmab

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic non-small cell lung cancer (NSCLC) of adenocarcinoma type, who have seen their disease progress after treatment. They may or may not have certain genetic changes in their cancer. Participants should be relatively active and well enough to perform daily activities (ECOG score 0-1).

Inclusion Criteria

My cancer may or may not have specific genetic changes.
My cancer can be measured by standard health scans.
Key
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Rina-S monotherapy. Treatment cycles last 3 weeks, with 1 to 5 visits per cycle. Average treatment duration is 12 months.

12 months
1 to 5 visits per 3-week cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Rina-S

Trial Overview

The study tests the effectiveness and safety of a drug called Rina-S as a solo treatment for NSCLC. All participants will receive Rina-S, with no placebos involved. Treatment can last up to an average of 12 months, depending on individual responses and side effects.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Rina-SExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Genmab

Lead Sponsor

Trials
76
Recruited
15,300+

Dr. Jan van de Winkel

Genmab

Chief Executive Officer since 2010

PhD in Immunology, University of Utrecht

Dr. Judith Klimovsky

Genmab

Chief Medical Officer since 2019

MD, University of Copenhagen

Citations

Study to Assess the Efficacy and Safety of Rina-S in ...

The purpose of this study is to evaluate how well Rina-S works against lung cancer. The treatment in this study is Rina-S monotherapy (by itself). All ...

Genmab Announces New Data Demonstrating ...

Genmab Announces New Data Demonstrating Investigational Rinatabart Sesutecan (Rina-S®) Achieved Anti-Tumor Activity in Heavily Pretreated ...

UCSD Non-Small Cell Lung Cancer Clinical Trials for 2026

This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid ...

Genmab's Rina-S: New Study Targets Lung Cancer with ...

This research is significant as it focuses on improving outcomes for NSCLC patients, a common and challenging type of lung cancer. Rina-S, the ...

NCT05579366 | Rinatabart Sesutecan (Rina-S, PRO1184 ...

This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors.

ASCO25: Genmab's Rina-S en route to 'blockbuster ...

Part of the market's potential is its increased safety over immunotherapies, though ocular toxicity, neuropathy, and interstitial lung disease ...

719MO A phase I/II study of rinatabart sesutecan (Rina-S) ...

No ocular toxicity or interstitial lung disease was observed. The emerging safety profile of Rina-S in Part B is consistent with Part A. For Part A OC and ...