What side effects are associated with this type of intervention?

Common treatments for lung cancer, such as chemotherapy and immunotherapy, have a range of side effects. Chemotherapy agents like docetaxel and carboplatin can cause fatigue, nausea, increased liver function tests, and neutropenia. Immunotherapy agents, such as pembrolizumab and durvalumab, can lead to immune-related adverse events including pneumonitis, rash, pruritus, and diarrhea. Additionally, combination therapies can increase the incidence of severe adverse events, such as bleeding and hypertension, as seen with ramucirumab plus docetaxel. These side effects highlight the need for careful monitoring and management during treatment.

What prior FDA approvals exist?

Several FDA-approved treatments for lung cancer target specific enzymes or pathways essential for cancer cell growth. For instance, Sotorasib and Adagrasib are approved for KRAS G12C-mutated NSCLC, inhibiting the KRAS protein. Capmatinib and Tepotinib are approved for MET exon-14-skipping mutations, targeting the MET protein. Additionally, Selpercatinib and Pralsetinib are approved for RET fusion-positive NSCLC, inhibiting the RET kinase. These treatments, like Selinexor, aim to disrupt critical pathways in cancer cell proliferation and survival.

What other types of research exist?

Promising novel alternatives to Selinexor for lung cancer patients include Furmonertinib, which has shown efficacy in EGFR mutation-positive NSCLC, and Selpercatinib, which has demonstrated favorable outcomes in RET fusion-positive NSCLC. Additionally, Tucatinib combined with capecitabine and trastuzumab has shown improved progression-free and overall survival in HER2-positive metastatic breast cancer with brain metastases, which may be relevant for lung cancer patients with similar profiles.

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Chemotherapy

Selinexor + Chemotherapy/Immunotherapy for Advanced Cancer

Phase 1

Waitlist Available

Led By Aung Naing, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Patients must have failed prior standard curative chemotherapy for their disease

Must not have

Evidence of complete or partial bowel obstruction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the time between the course 1 start date and the date of disease progression or death, whichever is reported first, assessed up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests selinexor, a drug that blocks enzymes needed for cancer cell growth, in combination with other standard treatments. Selinexor has been tested in many studies for various high-grade cancers. It targets patients with advanced cancers that are hard to treat. The goal is to find the best dose and understand the side effects.

Who is the study for?

This trial is for adults with advanced cancers that have spread and can't be cured or controlled. They should be relatively healthy (ECOG 0-1), able to take oral meds, not pregnant, willing to use contraception, and recovered from recent treatments/surgeries. It's not for those with certain heart issues, infections, gut blockages, brain tumors or a history of severe immune reactions from past immunotherapies.

What is being tested?

The study tests Selinexor combined with various standard chemo or immunotherapy drugs in patients with advanced cancer. The goal is to find the safest dose of Selinexor that works best alongside these treatments by observing its effects on cancer cell growth.

What are the potential side effects?

Selinexor may cause fatigue, nausea, loss of appetite, blood count changes and other side effects typical of chemotherapy like hair loss and increased risk of infection. Side effects vary based on the combination of drugs used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My previous chemotherapy aimed at curing my disease did not work.

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I can swallow and keep down pills.

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My liver and kidney functions are within normal ranges.

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I have a confirmed cancer diagnosis, not including blood or brain cancer, needing treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a blockage in my intestines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the time between the course 1 start date and the date of disease progression or death, whichever is reported first, assessed up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the time between the course 1 start date and the date of disease progression or death, whichever is reported first, assessed up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and the time between the course 1 start date and the date of disease progression or death, whichever is reported first, assessed up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Disease control rate (complete response, partial response + stable disease for at least 6 months

Incidence of adverse events

Objective tumor response rate (complete response + partial response)

+2 more

Side effects data

From 2022 Phase 3 trial • 402 Patients • NCT03110562

43%

Weight decreased

29%

Cough

29%

Thrombocytopenia

29%

Nausea

29%

Decreased appetite

21%

Anaemia

21%

Fatigue

21%

Constipation

21%

Diarrhoea

14%

Oedema peripheral

14%

Pneumonia

14%

Neuropathy peripheral

14%

Paraesthesia

14%

Cataract

14%

Vomiting

14%

Headache

Fungal skin infection

Urinary tract infection

Asthma

Disturbance in attention

Respiratory syncytial virus infection

Neutropenia

Peripheral swelling

Mental status changes

Lower respiratory tract infection

Hyperthyroidism

Back pain

Pain in extremity

Hyponatraemia

Skin lesion

Oropharyngeal pain

Pyrexia

Cardiac failure

Hepatitis

Pharyngitis

Pollakiuria

Non-cardiac chest pain

C-reactive protein increased

Taste disorder

Haemorrhagic transformation stroke

Abdominal pain

Insomnia

Dyspepsia

Haemoglobin decreased

Infection

Hyperglycaemia

Toothache

Ecchymosis

Upper respiratory tract infection

Nasopharyngitis

Viral infection

Hypertension

Muscular weakness

Bronchiectasis

Basal cell carcinoma

Hypophagia

100%

80%

60%

40%

20%

Study treatment Arm

SdX Arm: Selinexor + Dexamethasone

SVdX Arm: Selinexor + Bortezomib + Dexamethasone

SVd Arm: Selinexor + Bortezomib + Dexamethasone

Vd Arm: Bortezomib + Dexamethasone

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

15Treatment groups

Experimental Treatment

Group I: Arms N and O (selinexor, nivolumab, ipilimumab)Experimental Treatment3 Interventions

Patients receive selinexor PO on days 1, 8, and 15, nivolumab IV over 30 minutes on day 1, and ipilimumab PO QD on day 1. Cycles repeat every 3 weeks for 4 cycles. Starting cycle 5, patients receive selinexor PO on days 1, 8, 15, and 22 and nivolumab IV over 30 minutes on day 1. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Group II: Arm P (selinexor, nivolumab, ipilimumab)Experimental Treatment3 Interventions

Patients receive selinexor PO on days 1, 8, 15, 22, 29, and 36, nivolumab IV over 30 minutes on days 1, 15, and 29, and ipilimumab PO QD on day 1. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Group III: Arm M (selinexor, nivolumabExperimental Treatment2 Interventions

Patients receive selinexor PO twice weekly (e.g. Monday/Wednesday or Tuesday/Thursday or Wednesday/Friday or Thursday/Saturday or Friday/Sunday) and nivolumab IV over 30 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group IV: Arm L (selinexor, pembrolizumab)Experimental Treatment2 Interventions

Patients receive selinexor PO twice weekly (e.g. Monday/Wednesday or Tuesday/Thursday or Wednesday/Friday or Thursday/Saturday or Friday/Sunday) and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group V: Arm K (selinexor, olaparib) (ARM CLOSED)Experimental Treatment2 Interventions

Patients receive selinexor PO on days 1, 8, 15, and 22 and olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group VI: Arm J (selinexor, capecitabine, oxaliplatin) (ARM CLOSED)Experimental Treatment3 Interventions

Patients receive selinexor PO on days 1, 8 and 15, capecitabine PO twice daily (BID) on days 1-14 and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. After 8 cycles, patients can continue single agent selinexor until disease progression.

Group VII: Arm I (selinexor, irinotecan hydrochloride) (ARM CLOSED)Experimental Treatment2 Interventions

Patients receive selinexor PO on days 1, 8 and 15 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. After 8 cycles, patients can continue single agent selinexor until disease progression.

Group VIII: Arm H (selinexor, FOLFIRI) (ARM CLOSED)Experimental Treatment4 Interventions

Patients receive selinexor PO on days 1, 8, 15 and 22, irinotecan hydrochloride IV over 90 minutes, fluorouracil IV continuously over 48 hours and leucovorin calcium IV over 2 hours on days 1 and 15. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After 6 cycles, patients can continue single agent selinexor until disease progression.

Group IX: Arm G (selinexor, topotecan hydrochloride) (ARM CLOSED)Experimental Treatment2 Interventions

Patients receive selinexor PO on days 1, 8, and 15 and topotecan hydrochloride IV over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. After 8 cycles, patients can continue single agent selinexor until disease progression.

Group X: Arm F (selinexor, carboplatin, pemetrexed) (ARM CLOSED)Experimental Treatment3 Interventions

Patients receive selinexor PO on days 1, 8, and 15 and carboplatin IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After 6 cycles, patients can continue single agent selinexor until disease progression.

Group XI: Arm E (selinexor, carboplatin, paclitaxel) (ARM CLOSED)Experimental Treatment3 Interventions

Patients receive selinexor PO on days 1, 8, and 15 and carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Treatment repeats every 21 days for up to 8 cycles depending con cancer type (6 cycles for non-small cell lung cancer, up to 8 cycles for ovarian cancer and other histological malignancies) in the absence of disease progression or unacceptable toxicity. After 6 to 8 cycles, patients can continue single agent selinexor until disease progression.

Group XII: Arm D (selinexor, doxorubicin, cyclophosphamide) (ARM CLOSED)Experimental Treatment3 Interventions

Patients receive selinexor PO on days 1, 8, and 15, doxorubicin IV over 90 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After 6 cycles, patients can continue single agent selinexor until disease progression.

Group XIII: Arm C (selinexor, eribulin)Experimental Treatment2 Interventions

Patients receive selinexor PO on days 1, 8, and 15 and eribulin IV over 1 hour on days 1 and 8. Combination treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After 6 cycles, patients can continue single agent selinexor until disease progression.

Group XIV: Arm B (selinexor, paclitaxel)Experimental Treatment2 Interventions

Patients receive selinexor PO twice weekly (e.g. Monday/Wednesday or Tuesday/Thursday or Wednesday/Friday or Thursday/Saturday or Friday/Sunday) on days 1-14. Patients then receive selinexor PO on days 1, 3, 8 and 10 and paclitaxel IV over 3 hours on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After 8 cycles of combination treatment, patients can continue single agent selinexor until disease progression.

Group XV: Arm A (selinexor, carboplatin) (ARM CLOSED)Experimental Treatment2 Interventions

Patients receive selinexor PO on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After 6 cycles, patients can continue single agent selinexor until disease progression.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

Fluorouracil

2014

Completed Phase 3

~11700

Ipilimumab

2015

Completed Phase 3

~3070

Irinotecan Hydrochloride

2010

Completed Phase 3

~2050

Oxaliplatin

2011

Completed Phase 4

~2890

Pembrolizumab

2017

Completed Phase 3

~2810

Topotecan

2017

Completed Phase 3

~2460

Olaparib

2007

Completed Phase 4

~2190

Capecitabine

2013

Completed Phase 3

~3960

Eribulin

2012

Completed Phase 3

~2740

Carboplatin

2014

Completed Phase 3

~6120

Doxorubicin

2012

Completed Phase 3

~8030

Nivolumab

2015

Completed Phase 3

~4010

Paclitaxel

2011

Completed Phase 4

~5370

Leucovorin Calcium

2011

Completed Phase 3

~12500

Pemetrexed

2014

Completed Phase 3

~5550

Selinexor

2020

Completed Phase 3

~1730

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common lung cancer treatments include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy kills rapidly dividing cells, including cancer cells, by damaging DNA or inhibiting cell division. Targeted therapies block specific molecules involved in tumor growth, such as EGFR, ALK, or KRAS mutations. Immunotherapy enhances the immune system's ability to fight cancer, often by inhibiting PD-1/PD-L1 pathways. Selinexor, a targeted therapy, blocks enzymes necessary for cancer cell growth. Understanding these mechanisms helps tailor treatments to individual patients, improving effectiveness and reducing side effects.