Next Clinical Trial for BAC - 1259019

The work over the last few years has really suggested that there is no specific intervention for BAC that should be treated differently from other kinds of lung adenocarcinoma. Specifically, treatment recommendations are most appropriately based on the presence or absence of a "driver mutation" like an EGFR mutation or an ALK rearrangement.

There's no information to base a recommendation for one trial over another. There's certainly a lot of interest in the immunotherapy trials such as anti-PD1 and anti-PD-L1 immune checkpoint inhibitors, and I'm also running the trial of DS-2248, but nobody can say what's a superior choice in this situation. I would say that there's no reason to expect that an ALK inhibitor therapy will be beneficial in someone who doesn't have an ALK rearrangement.

Good luck.

-Dr. West

"Choices are PD-L1 trial with MPDL3280A or tiral for CC223 +tarceva (Mtor) or a trial with XL184 plus Tarceva. Farther away, but doable is also a trial of DS-2248 – an HSP90 inhibitor. "

All of these seem like reasonable options for BAC. As you have seen, it takes time to be screened for these trials, and only a proportion of those screened will end up qualifying. So my suggestion is to get scheduled to be screened for your top choices of trials. That way, if you don't end up qualifying for your first choice, you have back-up options to fall back on in an expedient way. Hope this helps.

The trial of DS-2248 in which I'm involved is a phase I study, which means that we're still trying to define the safety/tolerability profile. I don't have enough experience with it to say what is realistic to expect -- I'm not sure that anyone knows yet. It's possible, though, that these reports of what an investigational drug "might" do is based not so much on a realistic expectation but on a legal document that mentions every conceivable horrible thing that could possibly occur in order to avoid legal responsibility for any problems. This is a rather common approach for informed consent documents, trying to list everything in a CYA ("cover your ass") form. But I would encourage speaking to the investigator for any further information.

-Dr. West

Hi Cathy,

The inclusion criteria for the trial is as follows:

1. Pathologically documented stage IIIB/IV non-small cell lung cancer.

2. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria, Version 1.1.

3. Subjects must meet 1 of the following 3 criteria in order to be included in Part 2:

a. Acquired resistance to reversible Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR-TKI), which should meet the following criteria:
Previous treatment with single-agent therapy (erlotinib or gefitinib).
Either of the following: A tumor that harbors an EGFR mutation known to be associated with drug sensitivity (i.e., G719X, exon 19 deletion, L858R, L861Q) -OR- Prior objective clinical benefit from EGFR-TKI, as evidenced by complete response (CR), partial response (PR), or stable disease (SD) ≥6 months as defined by RECIST or World Health Organization criteria.
Systemic progression of disease as defined by RECIST or WHO criteria while treatment with gefitinib or erlotinib.
No intervening therapy other than EGFR-TKIs (erlotinib and gefitinib) after progression on an EGFR-TKI.
Pre-treatment biopsy (performed via bronchoscopy or imaging guidance) for molecular testing of the tumor is desired but not mandatory for enrollment in Stage 1. However, pre-treatment biopsy within 21 days prior to the first day of treatment is required for enrollment in Stage 2.
b. Presence of ALK fusion gene in the tumor demonstrated by FISH and the subject has acquired resistance to ALK inhibitor therapy.
c. Presence of ALK fusion gene in the tumor demonstrated by FISH and the subject has progressed on chemotherapy and has not been treated with ALK inhibitor therapy.
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It seems that your treatment with Xalkori would probably disqualify you under the first and third (3a and 3c) criteria, but that you might qualify under 3b. But the best way to find out whether treatment with Afatinib would disqualify you would be to contact one of the trial centers. You can read about the trial here: http://www.clinicaltrials.gov/ct2/show/NCT01288430?term=DS-2248&rank=1

JimC
Forum moderator

I agree that the most appropriate course of action would be to have your case and potentially records reviewed by people at a center running the trial. Because we're providing general information here, we can't delve deeply into the specific details of any single person's situation.

Good luck.

-Dr. West