Crizotinib for Lung Cancer

(Drugs-SNPs Trial)

Not currently recruiting at 1 trial location

Overseen By Han Xu, MD/PhD/FAPCR

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2 & 3

Sponsor: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

Must be taking: Raloxifene

Must not be taking: Other anti-cancer therapies

Disqualifiers: Mastectomy, Pregnancy, Breast-feeding, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how genetic differences affect the effectiveness and side effects of Raloxifene, a medication used for breast cancer prevention, in patients with lobular carcinoma in situ (LCIS). Researchers aim to understand how variations in specific genes might influence patient responses to treatment. Participants will be divided into two groups, each receiving a different version of Raloxifene alongside chemotherapy. The trial seeks patients diagnosed with LCIS who have had a breast biopsy confirming the condition and are suitable for further biopsy and blood tests. Additionally, the trial will explore Crizotinib (also known as Xalkori), a lung cancer treatment, to assess its potential benefits in this context. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to important advancements in breast cancer prevention.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it excludes those who cannot stop other anti-cancer therapies. 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 has shown that crizotinib has been widely studied in people with advanced non-small-cell lung cancer (NSCLC). One study found that crizotinib improved quality of life and reduced lung cancer symptoms more effectively than chemotherapy. Safety data from large studies showed that crizotinib is generally well-tolerated. Common side effects include vision problems, nausea, and diarrhea, but these are often manageable.

Raloxifene, tested in the trial for breast cancer, is already FDA-approved for other uses, indicating its safety has been reviewed and found acceptable for those uses. Common side effects include hot flashes and leg cramps, which are usually not severe.

Both treatments have demonstrated good safety records in previous research. However, it is always important to consider possible side effects and discuss them with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about crizotinib for lung cancer because it offers a unique approach compared to standard treatments like chemotherapy and radiation. Crizotinib is a targeted therapy that specifically blocks certain proteins involved in the growth of cancer cells, particularly those with specific genetic mutations, such as ALK or ROS1. This precision targeting can lead to fewer side effects and improved outcomes for patients with these mutations. Unlike traditional treatments that affect both healthy and cancerous cells, crizotinib's selective action allows it to be more effective in halting the progression of cancer.

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

Research has shown that Crizotinib can help treat certain types of lung cancer. One study found that 66% of patients experienced tumor shrinkage or disappearance. Patients with ALK-positive lung cancer reported better symptom relief and quality of life compared to those who received chemotherapy. Crizotinib also proved effective and safe for treating ROS1-rearranged lung cancer. Overall, these studies suggest Crizotinib could be a promising option for some lung cancer patients. ^{2 3 6 7 8}

Who Is on the Research Team?

Han Xu, MD/PhD/FAPCR

Principal Investigator

Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701

Han Xu, MD/PhD/FAPCR

Principal Investigator

Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701

Han Xu, MD/PhD/FAPCR

Principal Investigator

Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701

Are You a Good Fit for This Trial?

This trial is for adults over 22 with non-small cell lung cancer (NSCLC) confirmed by a lung tissue biopsy. Participants must have measurable disease, good performance status, and proper organ function. They cannot be pregnant or breastfeeding, have serious bleeding tendencies or allergies to drugs, be undergoing other cancer treatments that can't stop, or have multiple cancers.

Inclusion Criteria

I am generally healthy and active.

My lung cancer was confirmed through a tissue biopsy.

Random and double blind

Exclusion Criteria

I have had a surgery to remove one of my lungs.

I have a condition that causes serious bleeding.

The prohibition of drug products

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive Raloxifene 60 mg daily to assess therapeutic efficacy and safety related to SNP genotyping

12 weeks

Regular visits for monitoring and blood draws

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Crizotinib

Trial Overview The study investigates how genetic differences in the ALK gene and CYP4503A gene affect the effectiveness and side effects of Crizotinib in NSCLC patients. It involves precise gene sequencing and compares standard Crizotinib treatment against a study variant under double-blind conditions.

How Is the Trial Designed?

Group I: Raloxifene - Usual Experimental Treatment 1 Intervention

* Generic-1 - Raloxifene * Chemotherapy * Generic-1 - raloxifene hydrochloride tablet * Raloxifene 60 mg taken orally daily * Usual Approach Group (Generic-1)

Group II: Raloxifene - Study Experimental Treatment 1 Intervention

* Generic-2 - Raloxifene * Chemotherapy * Generic-2 - Raloxifene tablet * Raloxifene 60 mg taken orally daily * Usual Approach Group (Generic-2)

Crizotinib is already approved in United States, European Union, Japan, Canada for the following indications:

Approved in United States as Xalkori for:

• Non-small cell lung cancer (NSCLC) with ALK rearrangements

Approved in European Union as Xalkori for:

• Non-small cell lung cancer (NSCLC) with ALK rearrangements

Approved in Japan as Xalkori for:

• Non-small cell lung cancer (NSCLC) with ALK rearrangements

Approved in Canada as Xalkori for:

• Non-small cell lung cancer (NSCLC) with ALK rearrangements

Who Is Running the Clinical Trial?

Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

Lead Sponsor

Trials

6

Recruited

2,400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5832290/

Real-world outcomes in patients with ALK-positive non-small ... Mean (sd) duration of crizotinib treatment was 8.7 (4.9) months. Objective response rate was 66% (69% for first-line recipients, 60% for second-/later-line).

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38819031/

5-Year Outcomes From the Phase III CROWN Study Lorlatinib Versus Crizotinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer: 5-Year Outcomes From the Phase III CROWN Study.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0169500224003507

Efficacy and safety of crizotinib in the treatment ... Crizotinib is safe and effective in treating ROS1-rearranged aNSCLC in first and later lines of therapy based on RWE.

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa1408440

First-Line Crizotinib versus Chemotherapy in ALK-Positive ... As compared with chemotherapy, crizotinib was associated with greater reduction in lung cancer symptoms and greater improvement in quality of ...

5. pfizer.com pfizer.com/news/press-release/press-release-detail/pfizer_presents_overall_survival_data_of_xalkori_in_patients_with_alk_positive_advanced_non_small_cell_lung_cancer

Pfizer Presents Overall Survival Data of XALKORI in ... Results indicated a numerical improvement in OS for patients treated with first-line XALKORI compared with chemotherapy, though this difference ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6637370/

Crizotinib in ROS1-rearranged advanced non-small-cell lung ... In the ongoing phase I PROFILE 1001 study, crizotinib showed antitumor activity in patients with ROS1-rearranged advanced non-small-cell lung cancer (NSCLC).

7. esmoopen.com esmoopen.com/article/S2059-7029(20)32425-X/fulltext

efficacy and safety of crizotinib in previously treated ... Final results of the large-scale multinational trial PROFILE 1005: efficacy and safety of crizotinib in previously treated patients with advanced/metastatic ALK ...

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.2016.34.15_suppl.9066

Crizotinib vs chemotherapy in ALK+ advanced non-small ... PROFILE 1007 demonstrated superior PFS with crizotinib vs standard-of-care chemotherapy in patients (pts) with ALK+ advanced NSCLC previously treated with 1 ...