LUX-Lung IO: A phase II, open label, non-randomised study of afatinib in combination with pembrolizumab in patients with locally advanced or metastatic squamous cell carcinoma of the lung

  • sponsor
    Boehringer Ingelheim
Updated on 24 November 2020
squamous cell carcinoma
lung cancer
chemotherapy regimen
platinum-based chemotherapy
metastatic squamous cell carcinoma
lung carcinoma


LUX-Lung IO: A phase II, open label, non-randomised study of afatinib in combination with pembrolizumab in patients with locally advanced or metastatic squamous cell carcinoma of the lung


This trial is an open-label, single arm phase II study assessing the tolerability and anti-tumour activity of afatinib when given in combination with a fixed dose of pembrolizumab in patients with squamous NSCLC, who progressed during or after first line platinum-based standard therapy and had no prior treatment with an immune checkpoint inhibitor or EGFR targeted therapy.

The patient’s condition may or may not improve if the patient joins this study. The patient may benefit from the patient’s tumor shrinking more and having a longer time before the tumor begins to grow again, but none of these benefits can be promised. The results of this study may help other people with the same condition in the future.

Condition Squamous cell carcinoma, Lung Cancer
Clinical Study IdentifierTX153056
SponsorBoehringer Ingelheim
Last Modified on24 November 2020


Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 0 yrs?
Gender: Male or Female
Do you have any of these conditions: Squamous cell carcinoma or Lung Cancer?
Pathologically confirmed diagnosis of NSCLC considered to be of squamous histology, including mixed histology, in the opinion of the investigator
Locally advanced (stage IIIb) or metastatic (stage IV) NSCLC not considered eligible for curative therapy
Documented disease progression or relapse (based on investigator's assessment) during or after completion of at least 2 cycles of platinum-based chemotherapy as first line treatment of Stage IIIB/IV SCC of the lung. This includes patients relapsing within 6 months of completing (neo) adjuvant/curative-intent chemotherapy or definitive chemoradiotherapy. Patients should be eligible to receive second line therapy in the opinion of the investigator
At least one target lesion (outside the brain) that can be accurately measured per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. In patients who only have one target lesion and a biopsy of the lesion is required; the baseline imaging must be performed at least two weeks after the biopsy
Availability and willingness to provide a fresh tumour tissue sample obtained after relapse or progression on or after prior therapy. In case a fresh biopsy cannot be obtained (e.g. inaccessible lesions or patient safety concern), an archived specimen may be submitted
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ function defined as all of the following in the protocol page 26
Recovery from major surgery or any previous anti-cancer or radiation therapy-related toxicity to ≤ CTCAE Grade 1 at C1_V1 (except for alopecia; stable sensory neuropathy must be ≤ CTCAE Grade 2)
At least 18 years of age or over the legal age of consent in countries where that is greater than 18 years at screening
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
Male or female patients. Women of childbearing potential (WOCBP)0F 1 and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly, starting with the screening visit and through 120 days after the last dose of pembrolizumab treatment and 2 weeks after last afatinib treatment, respectively, as listed in the protocol. A list of contraception methods meeting these criteria is provided in the patient information. For further detail refer to Section
Note: Female patients of childbearing potential must have a negative urine or
serum pregnancy test within 72 hours prior to taking study medication. If the
urine test is positive or cannot be confirmed as negative, a serum pregnancy
test will be required. The serum pregnancy test must be negative for the
patient to be eligible

Exclusion Criteria

Prior therapy with any immune checkpoint inhibitor; however, prior (neo) adjuvant checkpoint inhibitor therapy is allowed if completed at least 12 months before relapse
Prior therapy with EGFR inhibiting drugs; however, prior EGFR-targeted (neo) adjuvant therapy is allowed if completed at least 12 months before relapse
Treatment with prior chemotherapy, non-EGFR targeted therapy, or anti-cancer hormonal treatment within 2 weeks prior to the first dose of trial treatment
Current or previous treatment with experimental therapy or use of an investigational device within 30 days prior to the first dose of trial treatment
Prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to the first dose of trial treatment
Received a live vaccine within 30 days prior to the first dose of trial treatment. Seasonal flu vaccines that do not contain live virus are permitted
Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. The use of physiologic doses of corticosteroids is allowed
Any history of or concomitant condition that, in the opinion of the investigator, would compromise the patient's ability to comply with the trial or interfere with the evaluation of the efficacy and safety of the test drugs
Radiotherapy within 4 weeks prior to start of treatment except as follows
Palliative radiotherapy to regions other than the chest is allowed up to 2 weeks prior to start of treatment
Single dose palliative radiotherapy for symptomatic metastasis within 2 weeks prior to start of treatment may be allowed but must be agreed with the Sponsor
Major surgery (according to the investigator's assessment) performed within 4 weeks prior to start of treatment or planned during the projected course of the study
Requirement or wish to continue the intake of restricted medications (see Section or any drug considered likely to interfere with the safe conduct of the trial
Known history of hypersensitivity to afatinib or any of its excipients
Known history of hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Note: Patients with previously treated brain metastases may participate
provided they are stable without evidence of progression by imaging (using the
identical imaging modality for each assessment, either MRI or CT scan) for at
least four weeks prior to the first dose of trial treatment and any neurologic
symptoms have returned to baseline), have no evidence of new or enlarging
brain metastases, and are not using steroids for at least 7 days prior to
trial treatment. This exception does not include carcinomatous meningitis
which is excluded regardless of clinical stability
Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, systemic corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids or current ILD/pneumonitis
Any history or presence of uncontrolled gastrointestinal disorders that could affect the intake and/or absorption of the study drug (e.g. nausea, vomiting, Crohn's disease, ulcerative colitis, chronic diarrhoea, malabsorption) in the opinion of the investigator
Active infectious disease requiring intravenous systemic therapy or which puts the patient at increased risk in the opinion of the investigator
Previous or concomitant malignancies at other sites than the lung, except
Effectively treated non-melanoma skin cancers
Effectively treated carcinoma in situ of the cervix
Effectively treated ductal carcinoma in situ
Other effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured
Known human immunodeficiency virus (HIV) (HIV 1/2 antibodies), active hepatitis B (e.g. HBsAg reactive) or hepatitis C (e.g. HCV RNA [qualitative] is detected)
History of active TB (Bacillus Tuberculosis)
History or presence of cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of =3, unstable angina or poorly controlled arrhythmia which are considered as clinically relevant by the investigator. Myocardial infarction within 6 months prior to start of treatment
Psychiatric, substance abuse disorders, or chronic alcohol abuse or any condition that in the investigator's opinion would interfere with cooperation with the requirements of the trial
History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation in the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator
Is pregnant or breastfeeding, expecting to conceive or father children within the projected duration of the trial, or do not agree to submit to the pregnancy testing required by this protocol, starting with the screening visit through 120 days after the last dose of pembrolizumab treatment and 2 weeks after last dose of afatinib treatment, respectively
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